MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD CONNECTOR; CONNECTOR DEVICE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter phone# (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed.And the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified number of the unknown bd connector experienced leakage.The following information was provided by the initial reporter: material no.: unknown; batch no.: unknown.It was reported that the green and white connector is low quality and difficult to attach.Per email: i have heard from a few of my hospitals that are evaluating the epidural trays that the connector is very low quality.Most hospitals have a hard time attaching the connector and possibly tightening too much, even after education from myself.Please note it would be very beneficial to add the blue and white adapter to all epidural trays as it is more user friendly.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

It was reported that an unspecified number of the unknown bd connector experienced leakage.The following information was provided by the initial reporter: material no.: unknown.Batch no.: unknown.It was reported that the green and white connector is low quality and difficult to attach.Per email: i have heard from a few of my hospitals that are evaluating the epidural trays that the connector is very low quality.Most hospitals have a hard time attaching the connector and possibly tightening too much, even after education from myself.Please note it would be very beneficial to add the blue and white adapter to all epidural trays as it is more user friendly.

• Brand Name: UNKNOWN BD CONNECTOR
• Type of Device: CONNECTOR DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8523126
• MDR Text Key: 142488620
• Report Number: 2243072-2019-00739
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other