MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367290

Device Problems Product Quality Problem (1506); Defective Device (2588)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

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 needle stick occurred with a bd vacutainer® multiple sample luer adapter.The following information was provided by the initial reporter, "we had another event last night with a luer adapter, this time leading to a needle stick.A different lot number was involved: 9129538.When our employee was trying to separate the butterfly from the luer, the luer unit broke.This time the transfer needle came out, losing its rubber sheath in the process and striking our phlebotomist in the hand.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.A review of the manufacturing records was completed for the incident lot and no issues were identified.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that a needle stick occurred with a bd vacutainer® multiple sample luer adapter.The following information was provided by the initial reporter, "we had another event last night with a luer adapter, this time leading to a needle stick.A different lot number was involved: 9129538.When our employee was trying to separate the butterfly from the luer, the luer unit broke.This time the transfer needle came out, losing its rubber sheath in the process and striking our phlebotomist in the hand.".

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8885702
• MDR Text Key: 154126748
• Report Number: 1024879-2019-01414
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672900
• UDI-Public: 50382903672900
• Combination Product (y/n): N
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 367290
• Device Lot Number: 9129538
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other