MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER ACD SOLUTION A BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364606

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Reinfusion (2403)

Event Date 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter addr 1: (b)(6).Pma/510(k)#: preamendment.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 7 bd vacutainer® acd solution a blood collection tubes experienced foreign matter in tube which was noted prior to use.The following information was provided by the initial reporter: when receiving the container, we found 7 damaged cases.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 8 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for foreign matter stain on tubes with the incident lot was observed.The brown substance seen on the product is dried additive.This type of defect will happen if a tube has been broken and the additive has leaked out and dried.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.

Event Description

It was reported that 7 bd vacutainer® acd solution a blood collection tubes experienced foreign matter in tube which was noted prior to use.The following information was provided by the initial reporter: when receiving the container, we found 7 damaged cases.

• Brand Name: BD VACUTAINER ACD SOLUTION A BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10237718
• MDR Text Key: 199110573
• Report Number: 1917413-2020-00557
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903646062
• UDI-Public: 50382903646062
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 364606
• Device Catalogue Number: 364606
• Device Lot Number: 9344850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other