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

Catalog Number	367297
Medical Device Problem Codes	Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after using a bd vacutainer® safety-lok¿ blood collection set, one (1) dirty needlestick injury occurred when the staff member tried to engage the safety device by sliding the sheath up over the needle.The safety device did not stay up over the needle and this led to the needlestick.No medical intervention has been provided to the staff, as the facility policy is to first test the patient for communicable diseases and then test the staff member if a positive result is obtained.
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.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported after using a bd vacutainer® safety-lok¿ blood collection set, one (1) dirty needlestick injury occurred when the staff member tried to engage the safety device by sliding the sheath up over the needle.The safety device did not stay up over the needle and this led to the needlestick.No medical intervention has been provided to the staff, as the facility policy is to first test the patient for communicable diseases and then test the staff member if a positive result is obtained.
Additional Manufacturer Narrative
The following fields have been updated with additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 16-oct-2024.Investigation summary: bd received 54 sets of samples for investigation.The samples were evaluated by visual examination, and no appearance defects on safety shields or winged hubs such as damage, molding defects was observed.Also, the activation of the safety shields was checked using 13 returned samples and nothing was found with the breakaway force, sustaining force, or security force.Additionally, 50 sets of our retained samples of the lot concerned were visually checked, and no abnormalities such as damage or molding defects of the safety shields or the wing hubs found.The activation of the safety shields was checked using 13 retained samples and no issues were found 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 of difficult to activate.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.Our business team regularly reviews the collected data for identification of emerging trends.".

• 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: 20273332
• Report Number: 2243072-2024-00983
• Device Sequence Number: 3469395
• Product Code: JKA
• UDI-Device Identifier: 30382903672975
• UDI-Public: (01)30382903672975(11)240711(17)270331(10)24D2681
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/02/2024

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 Catalogue Number: 367297
• Device Lot Number: 24D2681
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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: Other
• Patient Sex: Unknown