MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367671
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.
Event or Problem Description
It was reported that bd vacutainer® sodium heparin (nh) 33 usp: 33 iu blood collection tubes under filled.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for underfill 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.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 photos, the customer¿s indicated failure mode for underfill with the incident lot 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.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® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7522980
• Report Number: 1917413-2018-01607
• Device Sequence Number: 19126686
• Product Code: JKA
• UDI-Device Identifier: 50382903676717
• UDI-Public: 50382903676717
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 367671
• Device Lot Number: 7157752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2018
• Supplement Date Received by Manufacturer: 02/03/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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