MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

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 Description

It was reported the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had under-fill or low draw of a tube with blood during use.This event occurred 5 times.The following information was provided by the initial reporter: the customer noticed "tubes did not fill correctly.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 10 retention samples from bd inventory were evaluated.10 production lot in-house retention samples were draw tested.All tubes were within specification limits.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.H3 other text : see h.10.

Event Description

It was reported the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had under-fill or low draw of a tube with blood during use.This event occurred 5 times.The following information was provided by the initial reporter: the customer noticed "tubes did not fill correctly.".

• Brand Name: BD VACUTAINER CPT NH: ~130 IU FICOLL: 2.0ML
• 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: 10234106
• MDR Text Key: 199110591
• Report Number: 1917413-2020-00559
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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: 11/30/2020
• Device Catalogue Number: 362780
• Device Lot Number: 9315088
• 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