MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLONTM PRO SAFETY 14 G IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393270

Device Problem Fail-Safe Design Failure (1222)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Device evaluation: result - a sample is available for evaluation but has not been received.One photo was received which shows the cannula tip exposed on the bottom of the needle cap.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5355074.Conclusion - bd was able to confirm the customer's indicated failure mode from evaluation of the returned photo.Without an actual sample, an absolute root cause for this incident cannot be determined.Once a sample is received, an evaluation will be performed and a supplemental submitted.

Event Description

It was reported the needle tip was not completely covered by the safety mechanism of the suspect device.The clinician sustained a needle stick injury.No interventions were provided to the clinician or patient."they just made a compression and a plaster on the wound.".

Manufacturer Narrative

Results: one used sample was returned for evaluation.The square cover of the safety mechanism was removed and a visual examination revealed no damage or abnormalities to the "shark fin" or v-clip.The catheter hub was not returned for evaluation.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue.As previously reported, a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5355074.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Remedial action required: although a root cause for this incident could not be determined, capa (b)(4) has been initiated to investigate the needle stick injury associated with this device.

• Brand Name: BD VENFLONTM PRO SAFETY 14 G IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• 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: 6405685
• MDR Text Key: 69992663
• Report Number: 8041187-2017-00027
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 393270
• Device Lot Number: 5355074
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 82497
• Patient Sequence Number: 1
• Patient Outcome(s): Other