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

Catalog Number 367281

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/28/2022

Event Type  Injury  

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the user identified difficulty activating the safety shield causing a needle stick injury post use.There was no reports of medical intervention noted.The following information was provided by the initial reporter.The customer stated: the observed defect is that even if you pull the tail it doesn¿t cover the needle completely or lock in for safety.The defect was observed after use to cover the needle (to prevent needle stick) before disposing used needle to sharps.It was reported by the customer that needle stick injury occurred when trying to safety cover.Customer reported that the butterfly wingset was not safe to close/activate safety closure to cover the needle.

Manufacturer Narrative

(b)(4).Bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure modes for defective safety mechanism resulting in a dirty needle stick injury with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to defective safety mechanism 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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure modes.Bd was not able to identify a root cause for the indicated failure modes.As stated in the instructions for use, please hold the end of safety shield and tubing, and slide the safety shield straight to cover the winged needle without holding wings.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure modes for defective safety mechanism resulting in a dirty needle stick injury with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to defective safety mechanism 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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure modes.Bd was not able to identify a root cause for the indicated failure modes.As stated in the instructions for use, please hold the end of safety shield and tubing, and slide the safety shield straight to cover the winged needle without holding wings.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the user identified difficulty activating the safety shield causing a needle stick injury post use.There was no reports of medical intervention noted.The following information was provided by the initial reporter.The customer stated: the observed defect is that even if you pull the tail it doesn¿t cover the needle completely or lock in for safety.The defect was observed after use to cover the needle (to prevent needle stick) before disposing used needle to sharps it was reported by the customer that needle stick injury occurred when trying to safety cover.Customer reported that the butterfly wingset was not safe to close/activate safety closure to cover the needle.

• 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
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15451360
• MDR Text Key: 300235713
• Report Number: 2243072-2022-01547
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903672813
• UDI-Public: 00382903672813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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: 367281
• Device Lot Number: 1K2111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention