MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BDVACUTAINER® CPT¿; BLOOD COLLECTION TUBE

Catalog Number 362780

Device Problem Break (1069)

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

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 glass breakage with the incident lot was observed.However, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for glass breakage with the incident lot was observed.Root cause description: based on the investigation, a root cause could not be determined.

Event Description

It was reported that a bdvacutainer® cpt¿ had broke when the customer attempted to removed the tube from the vacutainer.It was removed when the customer noticed it was failing to fill as well as the other tubes.There was report of exposure to the blood, but no medical intervention was reported.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that a bdvacutainer® cpt¿ had broke when the customer attempted to removed the tube from the vacutainer.It was removed when the customer noticed it was failing to fill as well as the other tubes.There was report of exposure to the blood, but no medical intervention was reported.

• Brand Name: BDVACUTAINER® CPT¿
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7749553
• MDR Text Key: 116212846
• Report Number: 1917413-2018-03148
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362780
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other