MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ EPIDURAL MINI-KIT; ANESTHESIA CONDUCTION KIT

Catalog Number 400273

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation results: a sample or photo was not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot #6123765.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that 3 cm of the catheter on a bd perisafe¿ epidural mini-kit remained inside the patient when removing 48hrs after insertion.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 7433310
• MDR Text Key: 105771878
• Report Number: 2618282-2018-00011
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 400273
• Device Lot Number: 6123765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other