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

Catalog Number	367285
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.G.5: pma / 510(k)#k980414 , k991088 h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hic, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 3 of 4.
Additional Manufacturer Narrative
The following field was updated with corrected information: b.3.Date of event: (b)(6) 2023.
Event or Problem Description
It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hiv, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 3 of 4.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 21-mar-2024.H.6 investigation summary: material #: 367285.Lot/batch #: 23d2211.Bd received 3 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure mode for difficult to activate safety shield with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and another 8 retention samples by functional testing and no issues were observed relating to difficult to activate safety shield 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 mode difficult to activate safety shield.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hic, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 3 of 4.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18970087
• Report Number: 2243072-2024-00440
• Device Sequence Number: 20403147
• Product Code: JKA
• UDI-Device Identifier: 50382903672856
• UDI-Public: (01)50382903672856
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 367285
• Device Lot Number: 23D2211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 05/02/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/07/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown