MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368656
Medical Device Problem Codes	Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
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 that the bd vacutainer® push button blood collection set with pre-attached holder experienced blood spatter/leakage during use.The following information was provided by the initial reporter: material no.368656, batch no.9158903.The needle was leaking where it attaches to the holder.Had never seen this before.Seemed like the tubes had air in them as well.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that the bd vacutainer® push button blood collection set with pre-attached holder experienced blood spatter/leakage during use.The following information was provided by the initial reporter: material no.368656 batch no.9158903.The needle was leaking where it attaches to the holder.Had never seen this before.Seemed like the tubes had air in them as well.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9225239
• Report Number: 1024879-2019-01849
• Device Sequence Number: 2606465
• Product Code: FMI
• UDI-Device Identifier: 50382903686563
• UDI-Public: 50382903686563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011984
• 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): 12/27/2019

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: 05/31/2021
• Device Catalogue Number: 368656
• Device Lot Number: 9158903
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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