MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367341
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd vacutainer® push button blood collection set, the device experienced failure of the product to contain blood or medication.The following information was provided by the initial reporter.The customer stated: it was reported that the butterfly tubing had a puncture in it.While drawing blood from patient butterfly tubing started dripping blood onto bed/nurse.It was noted butterfly tubing had puncture in it.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set, the device experienced failure of the product to contain blood or medication.The following information was provided by the initial reporter.The customer stated: it was reported that the butterfly tubing had a puncture in it.While drawing blood from patient butterfly tubing started dripping blood onto bed/nurse.It was noted butterfly tubing had puncture in it.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for investigation.Therefore, 30 retention samples from bd inventory were evaluated by visual examination and leak testing and no issues were observed relating to damaged tubing 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 damaged tubing.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 12295738
• Report Number: 1024879-2021-00568
• Device Sequence Number: 3210485
• Product Code: JKA
• UDI-Device Identifier: 50382903673419
• UDI-Public: 50382903673419
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• 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): 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 367341
• Device Catalogue Number: 367341
• Device Lot Number: 0246266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1