MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ESR BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	369741
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
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 #: 8187772, medical device expiration date: 2020-01-31, device manufacture date: 2018-07-06.Medical device lot #: 8099645, medical device expiration date: 2019-10-31, device manufacture date: 2018-04-09.Medical device lot #: 8156835, medical device expiration date: 2019-12-31, device manufacture date: 2018-06-05.Device evaluated by mfr: 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 underfill occurred during use with bd vacutainer® esr blood collection tubes.The following information was provided by the initial reporter, "received call, she stated 5 tubes were under filling.On 2019-06-25- spoke to the customer directly.She received the product return notification and will send in the tubes.She is interested in the investigation findings, particularly if the tubes fill completely closer to sea level.She thinks that the high altitude may contribute to the short fill.They order the coagulation tubes for high altitude.She had no other questions." 5 occurrences were reported.
Event or Problem Description
It was reported that underfill occurred during use with bd vacutainer® esr blood collection tubes.The following information was provided by the initial reporter, "received call, she stated 5 tubes were under filling.(b)(6) 2019- spoke to the customer directly.She received the product return notification and will send in the tubes.She is interested in the investigation findings, particularly if the tubes fill completely closer to sea level.She thinks that the high altitude may contribute to the short fill.They order the coagulation tubes for high altitude.She had no other questions." 5 occurrences were reported.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for underfill with the incident lot was not observed.Evaluation/testing of the customer samples was performed and underfill 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.Bd has initiated further investigation relating to this issue through capa#260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for underfill with the incident lot was not observed.Further investigation has been initiated through capa#260774.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: capa#260774 has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

• Brand Name: BD VACUTAINER® ESR BLOOD COLLECTION TUBES
• 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: 8781265
• Report Number: 1917413-2019-01741
• Device Sequence Number: 16655041
• Product Code: JKA
• UDI-Device Identifier: 50382903697415
• UDI-Public: 50382903697415
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 07/25/2019

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: 369741
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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