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

Model Number	367298
Medical Device Problem Codes	Product Quality Problem (1506); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/20/2020
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 (b)(4) 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.(b)(4).
Event or Problem Description
It was reported that during use with a bd vacutainer® safety-lok¿ blood collection set there was a retraction issue which led to needlestick injury.The following information was provided by the initial reporter: it was reported that there was an accidental needle stick injury due to the needle not fully retracting.
Event or Problem Description
It was reported that during use with a bd vacutainer® safety-lok¿ blood collection set there was a retraction issue which led to needlestick injury.The following information was provided by the initial reporter: it was reported that there was an accidental needle stick injury due to the needle not fully retracting.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, retention samples from bd inventory were evaluated by visual examination functional testing and no issues were observed relating to does not retract 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.H3 other text : see h.10.

• 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: 10561004
• Report Number: 2243072-2020-01463
• Device Sequence Number: 3144284
• Product Code: JKA
• UDI-Device Identifier: 50382903672986
• UDI-Public: 50382903672986
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• Number of Events Summarized: 1
• Summary Report (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): 10/13/2020

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: 06/30/2022
• Device Model Number: 367298
• Device Catalogue Number: 367298
• Device Lot Number: 9F2281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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