MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use glass tubes are breaking with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter, translated from portuguese to english: in handling the tubes are breaking very easily, with a risk of biological accident.
Event or Problem Description
It was reported that during use glass tubes are breaking with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter, translated from portuguese to english: in handling the tubes are breaking very easily, with a risk of biological accident.
Additional Manufacturer Narrative
Investigation: bd had not received samples, but 1 photo were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for glass breakage with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) 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: 10488177
• Report Number: 1917413-2020-00784
• Device Sequence Number: 16949317
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 9315472
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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