ARROW FLEXBLOCK KIT: ECHO CATH, 17GX4CM, STM NDL
Received Oct 16, 2014 · Event occurred Sep 22, 2014
Report 1036844-2014-00412 · MDR key 4188217
Device
Generic name
Anesthesia Conduction Kit
Manufacturer
Arrow Intl., Inc.Catalog number
FB-19604-K
Lot number
23F14E1285
Product problems
- Kinked
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT ALLEGES THAT THE CATHETER WOULD NOT THREAD THROUGH THE NEEDLE. CATHETER APPEARED TO BE KINKED. THE ALLEGED DEFECT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE STIMULATING NEEDLE AND FLEXBLOCK CATHETER WITH NO RELEVANT FINDINGS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE DHR FOR THE STIMULATING NEEDLE AND FLEXBLOCK CATHETER WERE REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE POTENTIAL CAUSE OF A CATHETER NOT THREADING THROUGH THE NEEDLE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.