inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received Mar 25, 2021 · Event occurred Jan 15, 2021

Report 3006260740-2021-00967 · MDR key 11570952

Device

Generic name

Stand, Infusion

Model number

N/A

Catalog number

PIC0220

Lot number

JUEW2307

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND BATCH HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, SAMPLE ANALYSIS AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A STATLOCK RETAINER DETACHMENT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. TWO PHOTO SAMPLES OF A STATLOCK SECUREMENT DEVICE WERE PROVIDED FOR EVALUATION. THE FIRST PHOTO SHOWS THE STATLOCK DEVICE ATTACHED TO THE PATIENT. A CATHETER IS SECURED TO THE STATLOCK RETAINER AND IS BEING HELD. THE CLINICIAN APPEARS TO BE LIFTING THE STATLOCK RETAINER AND THE RETAINER IS SHOWN TO BE PARTIALLY DETACHED FROM THE SECUREMENT PAD. THE SURFACE OF THE RETAINER CANNOT BE CLEARLY INSPECTED; HOWEVER, IT IS LIKELY THAT ADHESIVE IS PRESENT AS THE RETAINER APPEARS TO BE PARTIALLY ADHERED. THE SECOND PHOTO SHOWS THE PRODUCT PACKAGING FOR STATLOCK PICC PLUS DEVICE. THE PACKAGING INDICATES PRODUCT LOT: JUEW2307. BASED ON THE PHOTO SAMPLES PROVIDED, POSSIBLE CONTRIBUTING FACTORS INCLUDE ADHESIVE WEAKENING DUE TO CLEANING SOLUTIONS AND EXCESSIVE MANIPULATION OF THE DEVICE. SINCE THE PHOTO SHOWED THE RETAINER BASE TO BE PARTIALLY DETACHED FROM THE SECUREMENT PAD, THE COMPLAINT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY EVIDENCE TO SUGGEST A MANUFACTURING RELATED ROOT CAUSE CONTRIBUTED TO THE REPORTED EVENT. A LOT HISTORY REVIEW (LHR) OF JUEW2307 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED "THE LINES TEAM REPORTED HAVING NUMEROUS ISSUES WITH THE WINGS ON STATLOCK BREAKING. ADDITIONAL INFO. RECEIVED 01/24/2021: THERE ARE MULTIPLE PEOPLE ON OUR TEAM COMPLAINING OF ISSUES WITH THE LOCKING TABS BREAKING OFF AND THE WINGS ACTUALLY SEPARATING FROM THE ADHESIVE. (B)(6) 2021- IN THE PHOTO PROVIDED FOR EVALUATION, THE STATLOCK RETAINER WAS PARTIALLY DETACHED FROM THE SECUREMENT PAD.