MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 367342

Device Problems Break (1069); Entrapment of Device (1212); Structural Problem (2506)

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

Event Date 02/05/2018

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.

Event Description

It was reported that during use, a bd vacutainer® winged safety push button blood collection set malfunctioned as the back-end needle broke off into the tube stopper while being removed from the hub.When attempting to pull the first blood tube out of the single use holder, the back-end needle attached to the back-end of the wing set resulting in the needle cannula sticking out of the top of the blood tube.Due to this malfunction the phlebotomist had to remove the wing set from the patient and stick them a 2nd time.There was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for the non-patient (np) end cannula separating from the luer of the incident lot was observed.Additionally, evaluation & testing of the customer samples was performed and no issues were found during separation/pull testing as all results met specifications.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.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for the np end cannula separating from the luer of the incident lot was observed.Additionally, evaluation & testing of the customer samples was conducted and all results met specifications.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: a capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

• Brand Name: BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7307001
• MDR Text Key: 101611946
• Report Number: 1024879-2018-00052
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/10/2018

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: Phlebotomist
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 367342
• Device Lot Number: 7320661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other