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 Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was glass breakage during use.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: the "cpt tube has been breaking in the centrifuge on two different occasions.The samples come from patients with infectious diseases.To avoid any risk for spreading, they have ordered new buckets to the centrifuges.".

Event Description

It was reported when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was glass breakage during use.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: the "cpt tube has been brekaing in the centrifuge on two different occasions.The samples come from patients with infectious diseases.To avoid any risk for spreading, they have ordered new buckets to the centrifuges.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to defective product as all samples met specifications.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 issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• 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: 11345029
• MDR Text Key: 232789669
• Report Number: 1917413-2021-00103
• 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: 03/18/2021

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
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 362780
• Device Lot Number: 0164638
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1