MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367729
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to stopper function 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 bd vacutainer® sodium fluoride: 30mg blood collection tubes stopper did not meet force specifications.This was discovered before use.The following information was provided by the initial reporter: material no: 367729.Batch no: 9184898.It was reported that during bd r&d testing, the tubes were observed with second time stopper removal forces that did not meet the minimum force specification.Event description per email states: during r&d testing, we observed some tubes with 2nd time stopper removal forces that did not meet the minimum force specification.We also observed 1 batch of tubes that did not meet the mean force specification.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 30MG 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: 9251235
• Report Number: 1917413-2019-02270
• Device Sequence Number: 3096078
• Product Code: JKA
• UDI-Device Identifier: 50382903677295
• UDI-Public: 50382903677295
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 01/31/2021
• Device Catalogue Number: 367729
• Device Lot Number: 9184898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/29/2019
• 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