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

Catalog Number 367257

Device Problem Break (1069)

Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced the cannula breaking off / pulling out.The following information was provided by the initial reporter.The customer stated: during a validation of safety-lok wingset in a customer, the bd company rep had a doubt about the performance and quality of the product.She has oriented the health staff to use the complete bd system (holder + wingset), however a nurse used a greiner holder (instead of bd) and the distal needle of the bd wingset has broken.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 1 photo was provided by the customer for investigation.The photo was reviewed and the indicated failure mode for np needle breaks off with the incident lot was observed.Additionally, retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to np needle breaks off as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode np needle breaks off.From the picture of the actual sample and the simulation test, it was considered an excessive torque was applied to the needle hub after screwing fg-la needle hub into greiner holder and the needle hub was broken off.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced the cannula breaking off / pulling out.The following information was provided by the initial reporter.The customer stated: during a validation of safety-lok wingset in a customer, the bd company rep had a doubt about the performance and quality of the product.She has oriented the health staff to use the complete bd system (holder + wingset), however a nurse used a greiner holder (instead of bd) and the distal needle of the bd wingset has broken.

• 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: 12271270
• MDR Text Key: 264955660
• Report Number: 2243072-2021-02009
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 367257
• Device Lot Number: 1A30A1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/28/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1