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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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® blood alcohol determinations sodium fluoride additive was abnormal.This occurred on 3 occasions before use.The following information was provided by the initial reporter: material no.367001, batch no.9036731.It was reported that the additive appeared to be dried and stuck to the side of the tube.He states that in some of the tubes (3 out of the 5 that he recently checked), the additive appears to be dried and stuck to the side of the tube, and he is not sure if he should use it.It is in a kit assembled by andwin kit packers.I explained that if the tubes do not appear normal, he should not use them.He might want to contact andwin to get replacement tubes.
Additional Manufacturer Narrative
Investigation: bd received samples and photos from the customer facility for investigation.The photos and samples were evaluated and the customer¿s indicated failure mode for additive abnormality with the incident lot was not observed.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.
Event or Problem Description
It was reported that bd vacutainer® blood alcohol determinations sodium fluoride additive was abnormal.This occurred on 3 occasions before use.The following information was provided by the initial reporter: material no.367001, batch no.9036731.It was reported that the additive appeared to be dried and stuck to the side of the tube.He states that in some of the tubes (3 out of the 5 that he recently checked), the additive appears to be dried and stuck to the side of the tube, and he is not sure if he should use it.It is in a kit assembled by adwin kit packers.I explained that if the tubes do not appear normal, he should not use them.He might want to contact adwin to get replacement tubes.

• 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: 8870635
• Report Number: 1917413-2019-01875
• Device Sequence Number: 19345026
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/28/2019

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: 02/28/2021
• Device Catalogue Number: 367001
• Device Lot Number: 9036731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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