MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393224

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 contrast leaked through top of port with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: iv contrast injected @ 3mls/sec through a 20g cannula.Due to faulty nature of the cannula the contrast leaked through the top port of the cannula.About 70mls of contrast came out of the top and leaked all over the patient's head, neck and chest, no contrast seen in the chest, therefore abandoned the scan.Had to re-cannulate and tap scan successful.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported that during use contrast leaked through top of port with a bd venflon¿ pro safety shielded iv catheter.The following information was provided by the initial reporter: iv contrast injected @ 3mls/sec through a 20g cannula.Due to faulty nature of the cannula the contrast leaked through the top port of the cannula.About 70mls of contrast came out of the top and leaked all over the patient's head, neck and chest, no contrast seen in the chest, therefore abandoned the scan.Had to re-cannulate and tap scan successful.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9907846
• MDR Text Key: 187261848
• Report Number: 8041187-2020-00187
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 393224
• Device Lot Number: 9291961
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other