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 Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown, medical device lot #: 0164635, medical device expiration date: 2021-06-30, device manufacture date: 2020-06-12.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 with the use of the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced under-fill or low draw of a tube with blood.The following information was provided by the initial reporter: translated to english.The customer stated "the tubes arrived but have had problems with them, apparently they have little vacuum and it is not possible to fill them completely.".

Event Description

It was reported with the use of the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced under-fill or low draw of a tube with blood.The following information was provided by the initial reporter: translated to english.The customer stated "the tubes arrived but have had problems with them, apparently they have little vacuum and it is not possible to fill them completely.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for evaluation.Therefore, ten (10) production lot in-house retention samples were tested with water and all were within the specification limits.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd was unable to determine the root cause of the customer's issue.

• 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: 10819300
• MDR Text Key: 216200805
• Report Number: 1917413-2020-01132
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362780
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1