MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿GEL & LITHIUM HEPARINN (LH) 126 UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367964
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.367964, batch no.9065839.It was reported that during use of the bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes there was rbc seepage past the gel barrier after centrifugation.This occurred on 42 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: during r&d testing in (b)(6), we observed rbc seepage past the gel barrier after centrifugation in the following bd vacutainer® pst¿ tube.The product information is below.Catalog #: 367964, batch #: 9065839, test date: nov 6, 2019.
Additional Manufacturer Narrative
H.6.Investigation summary bd received samples from the customer facility for investigation.The samples were evaluated and all product specifications were met.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.H3 other text : see section h.10.
Event or Problem Description
Material no.367964 batch no.9065839.It was reported that during use of the bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes there was rbc seepage past the gel barrier after centrifugation.This occurred on (b)(4) separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: during r&d testing in franklin lakes, we observed rbc seepage past the gel barrier after centrifugation in the following bd vacutainer® pst¿ tube.The product information is below.Catalog #: 367964.Batch #: 9065839.Test date: (b)(6) 2019.

• Brand Name: BD VACUTAINER® PST¿GEL & LITHIUM HEPARINN (LH) 126 UNITS 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: 9363472
• Report Number: 1917413-2019-02416
• Device Sequence Number: 14062537
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• 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): 01/14/2020

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: 03/31/2020
• Device Catalogue Number: 367964
• Device Lot Number: 9065839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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