MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22GX.25MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER SAFETY PORTED CATHETERS

Catalog Number 393222

Device Problem Mechanical Problem (1384)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/22/2016

Event Type  Injury  

Manufacturer Narrative

Medical device brand name: 22 g x. 25 mm bd venflon¿ pro safety peripheral safety iv catheter with injection valve. Device evaluation: a sample has been received for evaluation. A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the anesthetist inserted the suspect device and when he pulled the needle out, the safety mechanism did not trigger. This resulted in a needle stick injury to the finger from the unprotected needle. The anesthetist followed the facility's needle stick protocol which included lab work. No results were provided but the patient is not known to have an infectious blood disease.

Manufacturer Narrative

Device evaluation: result - one actual used sample was received by the manufacturer for evaluation. It was visually observed that the tether foil had detached from the needle protection mechanism. No visual damage was observed. A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5141276. A maintenance review revealed no abnormality in preventive maintenance and calibration that could have influenced the reported defect. It is suspected that cam guiding plate wear and tear caused the tether to not be properly assembled onto the needle cap. Conclusion - bd was able to confirm the customer's indicated failure mode based on the investigation of the returned sample. A probable root cause for this incident is wear and tear to the cam guiding plate. Non-capa corrective actions have been initiated.

• Brand Name: 22GX.25MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: SAFETY PORTED CATHETERS
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5723176
• MDR Text Key: 47334387
• Report Number: 8041187-2016-00041
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 393222
• Device Lot Number: 5141276
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/14/2016 Patient Sequence Number: 1