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

Model Number	367297
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For (b)(4) manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an (b)(4) manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: 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 sticky safety lock 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.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set device experienced needle stick injuries.The following information was provided by the initial reporter.The customer stated: "multiple needle sticks recently due to sticky action of the safety lock movement." it was reported by rn manager they are experiencing multiple needle sticks.

• 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: 11888643
• Report Number: 2243072-2021-01540
• Device Sequence Number: 3399819
• Product Code: JKA
• UDI-Device Identifier: 50382903672979
• UDI-Public: 50382903672979
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 05/10/2021

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 Model Number: 367297
• Device Catalogue Number: 367297
• Device Lot Number: 0L0281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/26/2021
• 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