MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364902

Device Problem Defective Device (2588)

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

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the holder will not detach with a bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported that (b)(6) will not disconnect from 20g nexivia.Once they are connected, the only way to get them apart is to cut the connection with trauma sheers.

Event Description

It was reported that the holder will not detach with a bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported that bd vacutainer luer-lok will not disconnect from 20g nexivia.Once they are connected, the only way to get them apart is to cut the connection with trauma sheers.

Manufacturer Narrative

H.6.Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for luer-lok will not disconnecting with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, no issues were observed relating to luer-lok will not disconnecting as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9310883
• MDR Text Key: 202583326
• Report Number: 2618282-2019-00282
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• 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: 01/29/2020

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: 05/31/2022
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 9158692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other