MAUDE Adverse Event Report: BECTON DICKINSON BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK; BLOOD COLLECTION SET

Catalog Number MBC6010

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd blood collection assembly with male luer lock broke on a patient to the point that they had to re-stick the patient.The blood could not be return with the patient because the item broke and they had a teammate who had to get a pliers to take the piece that had broken off out.

Manufacturer Narrative

Additional information: bd is conducting a voluntary medical device recall for multiple lots of the bd blood collection assembly with male luer lock based on confirmed complaints of a breakage in the luer.This issue could cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis.As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.Please reference bd recall #: pas-19-1355-fa, associated with res82317.

Event Description

It was reported that a bd blood collection assembly with male luer lock broke on a patient to the point that they had to re-stick the patient.The blood could not be return with the patient because the item broke and they had a teammate who had to get a pliers to take the piece that had broken off out.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.However, bd has conducted further investigation relating to this issue through a capa where improvement opportunities have been identified and are in the process of being implemented.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation activities have been conducted through a capa where improvement opportunities have been identified.As a result, these improvements are being implemented to help reduce further occurrences.Root cause description: although no samples or photos were available for evaluation, a capa was conducted to document further investigation and root cause analysis relating to this issue.The investigation has identified improvement opportunities in the manufacturing process and as a result, these improvements are being implemented to help reduce further occurrences.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue.The investigation has identified improvement opportunities in the manufacturing process and as a result, these improvements are being implemented to help reduce further occurrences.

Event Description

It was reported that a bd blood collection assembly with male luer lock broke on a patient to the point that they had to re-stick the patient.The blood could not be return with the patient because the item broke and they had a teammate who had to get a pliers to take the piece that had broken off out.

• Brand Name: BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8371945
• MDR Text Key: 139099335
• Report Number: 2243072-2019-00339
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K172763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

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: MBC6010
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/06/2019; 02/06/2019
• Supplement Dates FDA Received: 03/08/2019; 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: PAS-19-1355-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other