MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® EST¿ PLASTIC TUBE WITH HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number	362725
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2018
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 #: 7181502.Medical device expiration date: 2018-12-31.Device manufacture date: 2017-06-30.Medical device lot #: 7296795.Medical device expiration date: 2019-04-30.Device manufacture date: 2017-10-23.Initial reporter phone#: (b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported and confirmed that 2 bd vacutainer® est¿ plastic tubes with hemogard¿ closure had no residual vacuum causing ¿under filling issues¿.There was no report of injury or medical interventions.
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 observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, the customer's indicated failure mode for underfill was 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-conformance's during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa.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 and retain samples, the customer¿s indicated failure mode for underfill with the incident lot was observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, the customer's indicated failure mode for underfill was not observed.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: a capa 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.Capa (b)(4).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® EST¿ PLASTIC TUBE WITH HEMOGARD¿ CLOSURE
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7308050
• Report Number: 9617032-2018-00044
• Device Sequence Number: 1316986
• Product Code: JKA
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 362725
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/02/2018
• 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