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

Catalog Number	367964
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one bd vacutainer® pst¿ gel and lithium heparin (lh) 126 units blood collection tube has been found with the stopper coming out during use.The following has been provided by the initial reporter: it was reported the tubes failed a 2nd stopper pullout force that was just below the minimum specification.Hello, during r&d testing in (b)(4), we had a 2nd stopper pullout force that was just below the minimum specification.Catalog number: 367964, batch number: 9095793, test date: (b)(6) 2019, data review date: 19 july 2019.
Additional Manufacturer Narrative
H.6.Investigation: the samples were tested/evaluated and the indicated failure mode for stopper pullout with the incident lot was not observed as 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.
Event or Problem Description
It has been reported that one bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tube has been found with the stopper coming out during use.The following has been provided by the initial reporter: it was reported the tubes failed a 2nd stopper pullout force that was just below the minimum specification.During r&d testing in franklin lakes, we had a 2nd stopper pullout force that was just below the minimum specification.Catalog number: 367964, batch number: 9095793, test date: (b)(6) 2019 and data review date: 19 july 2019.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 126 UNIT 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: 8847774
• Report Number: 1917413-2019-01848
• Device Sequence Number: 2361561
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 04/30/2020
• Device Catalogue Number: 367964
• Device Lot Number: 9095793
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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