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

Model Number	367964
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
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 the rubber stopper remained in the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tube during r&d testing for stopper removal forces.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: during r&d testing, we observed some tubes with 2nd time stopper removal forces that did not meet the minimum and/or mean force specification.The product information is listed below.Catalog # batch # test date data review date observation 367964 9095794 11 nov 2019 13 nov 2019 did not meet minimum force specification 367729 9241023 12 nov 2019 13 nov 2019 did not meet mean force specification 367729 9241024 12 nov 2019 13 nov 2019 did not meet mean force specification.
Additional Manufacturer Narrative
H.6.Investigation: bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for stopper pull out 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 was reported that the rubber stopper remained in the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tube during r&d testing for stopper removal forces.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: during r&d testing, we observed some tubes with 2nd time stopper removal forces that did not meet the minimum and/or mean force specification.The product information is listed below.Catalog # batch # test date data review date observation 367964 9095794 (b)(6)2019 (b)(6)2019 did not meet minimum force specification 367729 9241023 (b)(6)2019 (b)(6)2019 did not meet mean force specification 367729 9241024 (b)(6)2019 (b)(6)2019 did not meet mean force specification.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 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: 9396783
• Report Number: 1917413-2019-02452
• Device Sequence Number: 2669426
• 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: 04/30/2020
• Device Model Number: 367964
• Device Catalogue Number: 367964
• Device Lot Number: 9095794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/02/2019
• 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