MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367961
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use the tube was under filling with a bd vacutainer® pst¿ gel and lithium heparin (lh) 65 units blood collection tubes.The following information was provided by the initial reporter: during r&d testing in (b)(4), we encountered 1 tube that did not fill during testing.The catalog number & batch information is: catalog #: 367961, batch #: 9126525, test date: (b)(6) 2019.
Event or Problem Description
It was reported that during use the tube was under filling with a bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes.The following information was provided by the initial reporter: during r&d testing in franklin lakes, we encountered 1 tube that did not fill during testing.The catalog number & batch information is: catalog#: 367961, batch#: 9126525, test date: 12 sept 2019.
Additional Manufacturer Narrative
H.6.Investigation: 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.Draw volume 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.H3 other text.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE
• 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: 9128938
• Report Number: 1917413-2019-02139
• Device Sequence Number: 19480098
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 367961
• Device Lot Number: 9126525
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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