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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

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.

Event Description

It was reported that glass tubes are breaking during centrifuge with a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml.The following information was provided by the initial reporter, translated from (b)(6) to english: a large number of cpt vacutainer tubes, whose ref and batch are shown in the photo attached as well as the quotation, break every day in our centrifuges.This leads to loss of samples, contamination of instruments and a risk for the technical staff, knowing that the samples contained are part of a covid-19 project and may be contaminated.This is a real safety and sample loss issue.

Manufacturer Narrative

H.6.Investigation summary bd had not received samples, but a photo was provided by the customer facility for investigation.The photo was evaluated and the customer's indicated failure mode for glass breakage with the incident lot was not observed.A review of the device history record was completed for the incident lot and, based on this review, 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 glass tubes are breaking during centrifuge with a bd vacutainer® cpt¿ nh: 130 iu ficoll¿: 2.0ml.The following information was provided by the initial reporter, translated from french to english: a large number of cpt vacutainer tubes, whose ref and batch are shown in the photo attached as well as the quotation, break every day in our centrifuges.This leads to loss of samples, contamination of instruments and a risk for the technical staff, knowing that the samples contained are part of a covid-19 project and may be contaminated.This is a real safety and sample loss issue.

Event Description

It was reported that glass tubes are breaking during centrifuge with a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml.The following information was provided by the initial reporter, translated from french to english: a large number of cpt vacutainer tubes, whose ref and batch are shown in the photo attached as well as the quotation, break every day in our centrifuges.This leads to loss of samples, contamination of instruments and a risk for the technical staff, knowing that the samples contained are part of a covid-19 project and may be contaminated.This is a real safety and sample loss issue.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for evaluation? yes? d.10 returned to manufacturer on:(b)(6) 2020.H.6.Investigation summary upon evaluation of the customer returned sample and photo, the customer¿s product issue was not observed during visual inspection of the tube.The product does not show ¿glass breakage¿.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 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: 10082971
• MDR Text Key: 192265172
• Report Number: 1917413-2020-00454
• 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,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 362780
• Device Lot Number: 9344851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other