Gibson Easy Needles 30G Extra Short Needles

Description of Event or Problem

UF/IMPORTER REPORT #: US-SEPTODONT- (B)(4). #1: DEVICE FRAGMENT EMBEDDED V29.0 (THE PATIENT WAS TRANSFERRED TO THE ORAL SURGERY TEAM FOR FOREIGN BODY REMOVAL.): FROM (B)(6) 2026 - SERIOUS - UNKNOWN. #2: NEEDLE BROKEN V29.0 (BREAKING OFF THE 30 GAUGE 10 MM NEEDLE AT THE HUB.): FROM (B)(6) 2026 - NOT SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: US-SEPTODONT- (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 18-JUN-2026 FROM DENTIST VIA DISTRIBUTOR BY EMAIL. INCIDENT DESCRIPTION NARRATIVE: THIS REPORT DESCRIBED DEVICE FRAGMENT EMBEDDED AND NEEDLE BROKEN ISSUE WITH THE SUSPECTED MEDICAL DEVICE GIBSON EASY NEEDLES 30G EXTRA SHORT NEEDLES PRIOR TO A TOOTH EXTRACTION PROCEDURE ON TOOTH #J, LOCATED IN THE MAXILLARY (UPPER) ALVEOLAR REGION. THIS EVENT OCCURRED IN AN ADOLESCENT PATIENT UNDER PROCEDURAL SEDATION. NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THE PATIENT. ON (B)(6) 2026, DURING THE ADMINISTRATION OF LOCAL ANESTHESIA, IN THE LEFT MIDDLE SUPERIOR ALVEOLAR REGION OF THE MAXILLA, THE PATIENT THRASHED, BREAKING OFF THE 30 GAUGE 10 MM NEEDLE AT THE HUB. THE NEEDLE WAS NOT INSERTED TO THE HUB DURING INFILTRATION. THE PATIENT HAD HEAD STABILIZATION BY EXPERIENCED PRACTITIONER AND USED A MOLT MOUTH PROP FOR INJECTION. TWO (2) LEAD GOWNS WERE USED AS WEIGHTED BLANKET TO CALM THE PATIENT. THE PATIENT WAS NOT RESTRAINED WITH PROTECTIVE STABILIZATION IN ADULT RESTRAINT DUE HIS AGE, NORMAL MENTAL CAPACITY AND PERCEIVED COMPLIANCE. CORRECTIVE TREATMENT: AFTER DISCOVERY OF NEEDLE BREAKAGE, THE PROCEDURE WAS STOPPED IMMEDIATELY. THE PATIENT'S PARENTS WERE IMMEDIATELY NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ORAL SURGERY TEAM FOR FOREIGN BODY REMOVAL. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. OTHER INFORMATION OF PRODUCT GIBSON EASY NEEDLES 30G EXTRA SHORT, BATCH NUMBER #F14032AA, EXPIRY DATE: 30-APR-2030. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). NO OTHER INFORMATION AVAILABLE. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE INFORMATION AVAILABLE, THE REPORT DESCRIBED DEVICE FRAGMENT EMBEDDED AND NEEDLE BROKEN ISSUE WITH THE SUSPECTED MEDICAL DEVICE GIBSON EASY NEEDLES 30G EXTRA SHORT NEEDLES PRIOR TO A TOOTH EXTRACTION PROCEDURE ON AN ADOLESCENT PATIENT UNDER PROCEDURAL SEDATION. DURING THE ADMINISTRATION OF LOCAL ANESTHESIA, IN THE LEFT MIDDLE SUPERIOR ALVEOLAR REGION OF THE MAXILLA, THE PATIENT THRASHED, BREAKING OFF THE 30 GAUGE 10 MM NEEDLE AT THE HUB. THE NEEDLE WAS NOT INSERTED TO THE HUB DURING INFILTRATION. THE PATIENT HAD HEAD STABILIZATION BY EXPERIENCED PRACTITIONER AND USED A MOLT MOUTH PROP FOR INJECTION. TWO (2) LEAD GOWNS WERE USED AS WEIGHTED BLANKET TO CALM THE PATIENT. THE PATIENT WAS NOT RESTRAINED WITH PROTECTIVE STABILIZATION IN ADULT RESTRAINT DUE HIS AGE, NORMAL MENTAL CAPACITY AND PERCEIVED COMPLIANCE. AFTER DISCOVERY OF NEEDLE BREAKAGE, THE PROCEDURE WAS STOPPED IMMEDIATELY. THE PATIENT'S PARENTS WERE IMMEDIATELY NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ORAL SURGERY TEAM FOR FOREIGN BODY REMOVAL. CAUSES OF NEEDLE BREAKAGE MAY INCLUDE BENDING OF NEEDLE PRIOR USE, INSERTION UP TO THE HUB, EXCESSIVE PRESSURE OR MOVEMENT OF THE NEEDLE DURING INJECTION, A SUDDEN MOVEMENT OF THE PATIENT DURING INJECTION AND/OR THE USE OF A NEEDLE SIZE INAPPROPRIATE TO THE TYPE OF PROCEDURE, OR THE USE OF THE NEEDLE IN SPITE OF AN OBSTACLE (E.G BONE) OR A QUALITY ISSUE. THEREFORE, A QUALITY DEFECT MAY BE SUSPECTED BUT USE ERROR/ABNORMAL CANNOT BE EXCLUDED AT THIS STAGE. PENDING QUALITY INVESTIGATIONS, NO ROOT COULD BE ESTABLISHED. INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE) IMPLEMENTED BY THE MANUFACTURER: BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, AND IN THE ABSENCE OF ANTERIORITY ON THE BATCH, NO CAPA IS REQUIRED.

Additional Manufacturer Narrative

REPROCESSED: UNK.