MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368587
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes.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 bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tube experienced difficulty moving the stopper during use.The following information was provided by the initial reporter: material no.368587, batch no.9095806.It was reported that a sample had failed the second stopper pullout test.I¿ve been managing some product testing and discovered a sample that had failed the second stopper pullout test.The samples are required to record a 2nd stopper pullout force of above 0.7lb, but this sample only recorded a pullout force of 0.155lb.Tube type: sodium fluoride 13x75mm, 4ml draw volume.Catalog number: 368587.Lot number: 9095806.
Additional Manufacturer Narrative
H.6.Investigation summary the samples were evaluated and the customer's indicated failure mode for stopper pullout with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to stopper pullout as all samples met specifications.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 bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tube experienced difficulty moving the stopper during use.The following information was provided by the initial reporter: material no.368587, batch no.9095806.It was reported that a sample had failed the second stopper pullout test.I¿ve been managing some product testing and discovered a sample that had failed the second stopper pullout test.The samples are required to record a 2nd stopper pullout force of above 0.7lb, but this sample only recorded a pullout force of 0.155lb.Tube type: sodium fluoride 13x75mm, 4ml draw volume catalog number: 368587 and lot number: 9095806.

• Brand Name: SEE H.10
• 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: 9527829
• Report Number: 1917413-2019-02575
• Device Sequence Number: 2884252
• Product Code: JKA
• UDI-Device Identifier: 50382903685870
• UDI-Public: 50382903685870
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 08/31/2020
• Device Model Number: 368587
• Device Catalogue Number: 368587
• Device Lot Number: 9095806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/25/2020
• 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