MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿EPIDURAL MINI-KIT:18GX3.5" WEISS NEEDLE,20GX36" POLYAMIDE CATHETER; ANESTHESIA EPIDURAL

Catalog Number 400273

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

No ncmr or scar was generated during the manufacturing of this lot.Conclusion: a photo is available for evaluation.Awaiting actual sample from customer.The sample will be evaluated upon receipt.A supplemental report will be filed upon completion of the investigation.

Event Description

Per report, the epidural catheter tip was cut and remained in the epidural space during insertion.Patient was transferred to another hospital, (b)(6) hospital, for an mri.The catheter tip was not detected.Patient was then transferred to (b)(6) hospital where she received a ct scan.The catheter was not detected.At the time of report, the patient had no adverse signs or symptoms related to this incident and was transferred back to original hospital for postnatal care.Patient was then discharged to home (b)(6) 2015 without further complications.

Manufacturer Narrative

Results - there was no photo or sample returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4321911.Conclusion - as there was no actual sample returned for evaluation, an absolute root cause for this incident cannot be determined.No sample returned for evaluation.

Manufacturer Narrative

Additional information - device evaluation: result - a physical sample was not submitted for evaluation.The photo submitted for evaluation shows two catheters.One of the catheters has the tip attached and the other does not.From the photo it cannot be determined if the catheter without the tip demonstrates a clean cut, which would mean that most assuredly was cut by the needle point when trying to remove the catheter.The catheter tip is not a part that can be dislodged separately from the catheter.Conclusion - the most probable root cause was that this tip was sheared off by trying to remove the catheter without first removing the needle during the procedure.Without an sample, an actual root cause for this incident cannot be determined.

Manufacturer Narrative

Device evaluation: result - a sample was received for evaluation.The catheter is missing a piece that was sheared off.The sample was observed under magnification and it could be identified that it had several cut marks before it was cut off.This indicates that the user tried to remove the catheter through the needle.While trying to remove the catheter this will continuously make contact with the needle point and damage and eventually cut the catheter.Conclusion - bd was able to confirm the customer's indicated failure mode.This defect is not related to manufacturing as the catheter is received as a raw material and no operations are performed on it.Bd concluded that the customer tried to remove the catheter without removing the needle.The customer likely attempted this several times as evidenced by the partial cuts.It is most likely that on the final attempt, the catheter was completely cut by the needle.The most probable root cause is customer technique.

• Brand Name: BD PERISAFE¿EPIDURAL MINI-KIT:18GX3.5" WEISS NEEDLE,20GX36" POLYAMIDE CATHETER
• Type of Device: ANESTHESIA EPIDURAL
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5086036
• MDR Text Key: 26113669
• Report Number: 2618282-2015-00001
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 400273
• Device Lot Number: 4321911
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2015; 01/18/2016; 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR