MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8303636, medical device expiration date: 2020-11-30, device manufacture date: 2018-10-30.Medical device lot #: 8276658, medical device expiration date: 2020-10-31, device manufacture date: 2018-10-03.Investigation summary bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure modes for glass breakage and improper stopper assembly with the incident lot was observed.A review of the device history record was completed for the incident lots 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 modes for glass breakage and improper stopper assembly with the incident lot was observed.Root cause description based on the investigation, a root cause could not be determined.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
Material no: 367001, batch no: 8187663.It was reported that before use of the bd vacutainer® blood alcohol determinations sodium fluoride tubes the tube had a broken lip as well as stopper was not fitting correctly in tube (too small).The following information was provided by the initial reporter: 1 tube was from cat.Number 367001, lot number 8303636 and had a broken lip (top of glass tube).5 tubes were from cat.Number 367001, lot number 8276658 and had stopper issues where the stopper was too small to fit properly and seal the tube.

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8847333
• Report Number: 1917413-2019-01845
• Device Sequence Number: 2088770
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• 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
• Report Date (Section B): 07/17/2019

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 Catalogue Number: 367001
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/31/2019
• 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