MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367338

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2255160.D.4.Medical device expiration date: 2024-09-30.H.4.Device manufacture date: 2022-09-12.D.4.Medical device lot #: 2164963.D.4.Medical device expiration date: 2024-06-30.H.4.Device manufacture date: 2022-06-13.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® push button blood collection set the product was damaged or open unit package/seal where sterility is compromised.The packaging/sterility event affected 499 devices.The following information was provided by the initial reporter.The customer stated: "the capsule packages were found deformed.There is uncertainty about safety in terms of sterilization and its application.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 2023-06-15.H.6.Investigation summary: "bd received 497 samples (2 from lot 2255160, 45 from lot 2276125, and 450 from lot 2164963) and 5 photos for investigation.The photos were reviewed and the customer¿s indicated failure modes for short count, empty unit package, and damaged packaging were observed.The customer samples were evaluated by visual examination and the indicated failure modes for short count, empty unit package, and damaged packaging with the incident lots were observed.Additionally, 50 retention samples from bd inventory of each reported lot number (150 total) were evaluated by visual examination and the issues of short count, empty unit package, and damaged packaging were not observed.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 has been confirmed for the indicated failure modes short count, empty unit package, and damaged packaging.Bd was not able to identify a root cause for the indicated failure modes.".

Event Description

It was reported when using the bd vacutainer® push button blood collection set the product was damaged or open unit package/seal where sterility is compromised.The packaging/sterility event affected 499 devices.The following information was provided by the initial reporter.The customer stated: "the capsule packages were found deformed.There is uncertainty about safety in terms of sterilization and its application.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17054632
• MDR Text Key: 317467498
• Report Number: 9617032-2023-00660
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: 50382903673389
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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
• Device Operator: Other
• Device Model Number: 367338
• Device Catalogue Number: 367338
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1