MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER BULK GEL; CPT GEL

Catalog Number 368586

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that p5a 5 gallon pail had air bubbles.This was discovered before use.The following information was provided by the initial reporter: material no.368586, batch no.9108673.It was reported air bubbles were witnessed in pail.We had to quarantine some gel due to air bubbles.We can¿t have bubbles in our application.

Event Description

It was reported that bd vacutainer bulk gel had air bubbles.This was discovered before use.The following information was provided by the initial reporter: material no.368586, batch no.9108673.It was reported air bubbles were witnessed in pail.We had to quarantine some gel due to air bubbles.We cannot have bubbles in our application.

Manufacturer Narrative

The following fields have been updated with corrections: describe event or problem: it was reported that bd vacutainer bulk gel had air bubbles.This was discovered before use.The following information was provided by the initial reporter: material no.368586, batch no.9108673.It was reported air bubbles were witnessed in pail.We had to quarantine some gel due to air bubbles.We cannot have bubbles in our application.Medical device brand name: bd vacutainer bulk gel.Common device name: cpt gel.

Manufacturer Narrative

Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for gel air bubbles with the incident lot was 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 bd vacutainer bulk gel had air bubbles.This was discovered before use.The following information was provided by the initial reporter: material no.368586, batch no.9108673.It was reported air bubbles were witnessed in pail.We had to quarantine some gel due to air bubbles.We can¿t have bubbles in our application.

• Brand Name: BD VACUTAINER BULK GEL
• Type of Device: CPT GEL
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8914848
• MDR Text Key: 156927224
• Report Number: 1024879-2019-01485
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/26/2019
• Device Catalogue Number: 368586
• Device Lot Number: 9108673
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 08/05/2019; 08/05/2019
• Supplement Dates FDA Received: 09/05/2019; 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other