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

Model Number	367297
Medical Device Problem Codes	Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed.As nipro is an oem manufacturing site.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 after use with bd vacutainer® safety-lok¿ blood collection set the safety feature is difficult to activate and needle stick injuries occurred.The user/patient impact was not reported.The following information was provided by the initial reporter: it was reported that there are multiple needle sticks recently due to sticky action of the safety lock movement.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to defective safety 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 defective safety.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that after use with bd vacutainer® safety-lok¿ blood collection set the safety feature is difficult to activate and needle stick injuries occurred.The user/patient impact was not reported.The following information was provided by the initial reporter: it was reported that there are multiple needle sticks recently due to sticky action of the safety lock movement.

• 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
• MDR Report Key: 12436691
• Report Number: 2243072-2021-02253
• Device Sequence Number: 16955339
• Product Code: JKA
• UDI-Device Identifier: 50382903672979
• UDI-Public: 50382903672979
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 367297
• Device Catalogue Number: 367297
• Device Lot Number: 0L0281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other