MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367338

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2024957, medical device expiration date: 2024-01-31, device manufacture date: 2022-01-24.Medical device lot #: 2080380, medical device expiration date: 2024-03-31, device manufacture date: 2022-03-21.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 there was failure of product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "during use the knob was damaged, air entered and the tubes do not fill." during use.

Manufacturer Narrative

H6: investigation summary; bd did not receive samples or photographs from the customer in support of this complaint.Therefore, 5 push button winged sets (from each batch number: 2024957, 2080380) from the bd inventory were taken at random and functionally tested and the issues of severed tubing or damaged product was not found.Bd was able to confirm the customer¿s indicated failure mode based on the dhr review only for the batch: 2024957, however retained samples test results for both batches: 2024957, 2080380 were satisfactory.The process was observed and root cause was identified and attributed to the manufacturing process for the lot 2024957.Bd was not able to identify a root cause for the indicated failure mode for the lot 2080380.The device history records were reviewed with no issues being identified for the batch: 2080380.All process and final inspections comply with specification requirements.Quality notification 200996642 was generated for the lot number 2024957; all product was dispositioned: all product has been 100% visually inspected for damaged tubing and all defected product had been scrapped.

Event Description

It was reported when using the bd vacutainer® push button blood collection set there was failure of product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "during use the knob was damaged, air entered and the tubes do not fill." during use.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-10-24.H.6.Investigation summary: bd received 100 samples (lot 2024957) and 100 samples (lot 2080380) from the customer in support of this complaint.An evaluation of 100 returned samples (lot 2024957) did not indicate damaged tubing, evaluation of 100 returned samples (lot 2080380) indicated 15 damaged tubing.5 push button winged sets from each batch number: 2024957, and 2080380 were taken at random and used to draw a tube with water and no defects were found.Bd was able to confirm the customer¿s indicated failure mode based on the returned samples.Bd was able to determine that the root cause for lot 2024957 was attributed to the faulty components within the manufacturing process.Bd was not able to identify a root cause for the indicated failure mode for lot 2080380.The device history records were reviewed with no issues being identified for batch: 2080380.All processes and final inspections comply with specification requirements.A quality notification was generated for lot number 2024957, and all affected product was dispositioned: all product has been 100% visually inspected for damaged tubing.

Event Description

It was reported when using the bd vacutainer® push button blood collection set there was failure of product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "during use the knob was damaged, air entered and the tubes do not fill." during use.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14938285
• MDR Text Key: 303733318
• Report Number: 1710034-2022-00340
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: 50382903673389
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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
• Date Manufacturer Received: 10/31/2022
• 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