MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367338

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed.And the franklin lakes fda registration number has been used for the manufacture report number.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.Medical device lot #: 22877990 was reported, however, this is not a lot# manufactured for this product.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 22 bd vacutainer® push button blood collection set had cracked tips and leaked.There was no report of patients, or patient impact.The following information was provided by the initial reporter, translated from french to english: the 22 boxes appear to be unusable due to concerns about leaks and cracked tips.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.This is a duplicate of mfr report # 9617032-2023-00254 that was reported for leakage.

Event Description

It was reported that 22 bd vacutainer® push button blood collection set had cracked tips and leaked.There was no report of patients, or patient impact.The following information was provided by the initial reporter, translated from french to english: the 22 boxes appear to be unitilizable due to concerns about leaks and cracked tips.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16550511
• MDR Text Key: 311750580
• Report Number: 2243072-2023-00403
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: (01)50382903673389
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/11/2023

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: 22877990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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