MAUDE Adverse Event Report: BECTON DICKINSON BD CONTINUOUS EPIDURAL TRAY WITH 18G X 3.5" WEISS EPIDURAL NEEDLE

Catalog Number 406049

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Inadequate Pain Relief (2388); Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2015

Event Type  Injury  

Manufacturer Narrative

The medical device expiration date is unknown as the lot number is unknown.Manufacturing location: bd corporate headquarters is used as the manufacturing site.The actual manufacturing site for this device, rr donnelley - global turnkey solutions, is an oem.The device manufacture date is unknown as the lot number is unknown.Device evaluation: a sample is available for evaluation but has not been received.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that a patient in labor and delivery had an epidural placed from a bd continuous epidural tray.The anesthesiologist reported the epidural was easy to place.A test dose of medication was given with no issues noted.A bolus dose was given approximately 30 minutes later and the rn reported that the patient was not getting any relief.Instead of re-bolusing the medication, the decision was made to remove the catheter and place a new one.Upon removal, approximately 5cm of catheter was missing, possibly sheared off at a 45 degree angle at the end of the catheter.As it was a larger patient, a ct scan and mri were performed to locate the tip of the catheter but were unsuccessful.After a consult with the neurologist, the decision was made to leave as is, with the possible tip of the catheter still inside the patient.The patient was discharged.

Manufacturer Narrative

Result - a sample was not returned for evaluation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion- bd was not able to confirm the customer's indicated failure mode.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD CONTINUOUS EPIDURAL TRAY WITH 18G X 3.5" WEISS EPIDURAL NEEDLE
• Type of Device: EPIDURAL TRAY
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5324856
• MDR Text Key: 34288383
• Report Number: 2243072-2015-00177
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 406049
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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