MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367001
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.Medical device lot #: 1195768; medical device expiration date: 2023-07-31; device manufacture date: 2021-07-14.Medical device brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.Medical device lot #: 1137362; medical device expiration date: 2023-05-31; device manufacture date: 2021-05-17.Medical device brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.Medical device lot #: 1098432; medical device expiration date: 2023-04-30; device manufacture date: 2021-04-08.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 bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg tubes are cracked.The following information was provided by the initial reporter: "customer states they are receiving tubes with hair line cracks.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 1 photo from the customer in support of this complaint.A visual examination of the photo was performed and revealed damage to the tube as a scratch can be seen.As no samples were received; the investigation was limited.Additionally, 95 retentions from lot 1195768, 100 retentions from lot 1137362, and 100 retentions from lot 1098432 were inspected with no issues being identified.Bd was able to confirm the customer¿s indicated failure mode with the photo provided; however, could not be duplicated in the retention samples.The exact cause for the customer¿s failure mode could not be determined.The device history records for all lots were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.H3 other text : see h.10.
Event or Problem Description
It was reported that bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg tubes are cracked.The following information was provided by the initial reporter: "customer states they are receiving tubes with hair line cracks.".

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15255467
• Report Number: 1917413-2022-00514
• Device Sequence Number: 15133615
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown