MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ PRE-ATTACHED BLOOD COLLECTION SET

Catalog Number 368653

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).Initial reporter email: (b)(6).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 the bd vacutainer® safety-lok¿ pre-attached blood collection set leaked blood into the hands of the phlebotomist from a hole in the tubing.No medical intervention or serious injury reported.Found during use.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for a small cut in the tubing 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.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 samples, the customer¿s indicated failure mode for a small cut in the tubing with the incident lot was observed.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® SAFETY-LOK¿ PRE-ATTACHED 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: 7322738
• MDR Text Key: 101979199
• Report Number: 1024879-2018-00075
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686532
• UDI-Public: 50382903686532
• Combination Product (y/n): N
• PMA/PMN Number: K991088
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 368653
• Device Lot Number: 7275864
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other