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

• 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

• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 393270
• Device Lot Number: 5355074
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• 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

• Removal/Correction Number: 82497

Patient Treatment Data

Date Received: 03/15/2017 Patient Sequence Number: 1