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

Model Number	367001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd vacutainer® blood alcohol determinations sodium fluoride: potassium oxalate tubes broke after use.The specimens were placed in the freezer, varying "from several days to weeks", and the glass broke during the thawing process.1 tube broke on 02/20/2020, with 4 other tubes breaking on an unknown date.The following information was provided by the initial reporter: "received call from customer whom stated they are experiencing glass breakage.This is occurring after specimen collection.Customer is placing specimen in freezer which varies from several days to weeks.Glass is breaking during thawing process.No exposure to blood, no serious injury, no erroneous results, no course of treatment change and no needle stick.Possible safety issue as glass shards were exposed but confirmed no injuries.Date of occurrence is today 02/20/2020 with one occurrence and an unknown date for 4 occurrences." "spoke with the customer, and referred her to the statement in the ifu under precautions that glass tube may break at or below 0c.She had the ifu and knew exactly where the statement was, but her group thought the breakage was unique to this lot#.I explained that all glass tubes may break at or below 0c.".
Additional Manufacturer Narrative
H.6.Investigation summary bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for glass breakage with the incident lot was not observed as all product specifications were met.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 the bd vacutainer® blood alcohol determinations sodium fluoride: potassium oxalate tubes broke after use.The specimens were placed in the freezer, varying "from several days to weeks", and the glass broke during the thawing process.1 tube broke on (b)(6) 2020, with 4 other tubes breaking on an unknown date.The following information was provided by the initial reporter: "received call from customer whom stated they are experiencing glass breakage.This is occurring after specimen collection.Customer is placing specimen in freezer which varies from several days to weeks.Glass is breaking during thawing process.No exposure to blood, no serious injury, no erroneous results, no course of treatment change and no needle stick.Possible safety issue as glass shards were exposed but confirmed no injuries.Date of occurrence is today (b)(6) 2020 with one occurrence and an unknown date for 4 occurrences." "spoke with the customer, and referred her to the statement in the ifu under precautions that glass tube may break at or below 0c.She had the ifu and knew exactly where the statement was, but her group thought the breakage was unique to this lot#.I explained that all glass tubes may break at or below 0c.".

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE: POTASSIUM OXALATE
• 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: 9819042
• Report Number: 1917413-2020-00260
• Device Sequence Number: 16703895
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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 Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: 8276658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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