MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD COLLECTION/INTRAVENOUS FLUID ADMINISTRATION SET

Catalog Number 367336

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that when pressing button to retract the needle, the safety mechanism of a bd vacutainer® push button blood collection set was separated and broken, resulted in exposing a needle.

Event Description

It was reported that when pressing button to retract the needle, the safety mechanism of a bd vacutainer® push button blood collection set was separated and broken, resulted in exposing a needle.

Manufacturer Narrative

Corrected information: medical device lot # 8082941 was changed to 8158950.Medical device expiration date: 2020-06-30.Device manufacture date: 2018-06-27.Additional information: device available for eval? yes.Returned to manufacturer on: 2019-01-24.

Event Description

It was reported that when pressing button to retract the needle, the safety mechanism of a bd vacutainer® push button blood collection set was separated and broken, resulted in exposing a needle.

Manufacturer Narrative

Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to separation of the housing upon retraction as all samples met specifications.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.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for separation of the housing upon retraction with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION/INTRAVENOUS FLUID ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8258741
• MDR Text Key: 133511777
• Report Number: 1710034-2019-00001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673365
• UDI-Public: 50382903673365
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 367336
• Device Lot Number: 8158950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other