MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367283

Device Problem Volume Accuracy Problem (1675)

Patient Problem Bruise/Contusion (1754)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd vacutainer® safety-lok¿ blood collection set has been found experiencing insufficient blood flow during use.The following has been provided by the initial reporter: it was reported that facility is having issues with the butterfly needles.Having to stick patients twice, patients are bruising, vein blows, no flashback, not flowing good.

Manufacturer Narrative

Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to insufficient blood flow 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.

Event Description

It has been reported that one bd vacutainer® safety-lok¿ blood collection set has been found experiencing insufficient blood flow during use.The following has been provided by the initial reporter: it was reported that facility is having issues with the butterfly needles.Having to stick patients twice , patients are bruising, vein blows, no flashback, not flowing good.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9106738
• MDR Text Key: 175838493
• Report Number: 2243072-2019-02093
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672832
• UDI-Public: 50382903672832
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 367283
• Device Lot Number: 8G2191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other