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

Catalog Number	367341
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set had a hole in the tubing and leaked blood.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 367341 batch no: 8288579.It was reported there was a hole in the tubing causing blood to leak out and cause an exposure.Quoted from clinician: "a nurse on ep 4-7 when drawing blood on one of her patients was unable to obtain the blood due to a miniature hole halfway down the tubing of the needle system.The blood from the patient, instead of going into the tube came out of the hole and caused a blood spill.The nurse tried another 25g butterfly needle from the same lot and found the same issue.This caused the patient to require repeat venipuncture." please send pre-paid mailing labels to send samples to quality for investigation.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for leakage with the incident lot was not observed; however, adhesive was observed on the tubing of one of the samples.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 customer samples, the customer¿s indicated failure mode for leakage with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.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.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set had a hole in the tubing and leaked blood.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 367341, batch no: 8288579.It was reported there was a hole in the tubing causing blood to leak out and cause an exposure.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8522826
• Report Number: 1024879-2019-00741
• Device Sequence Number: 13831947
• Product Code: JKA
• UDI-Device Identifier: 50382903673419
• UDI-Public: 50382903673419
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• 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): 05/21/2019

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: 10/31/2020
• Device Catalogue Number: 367341
• Device Lot Number: 8288579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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