MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON 24GA 0.7MM OD 19MM L INDIA; INTRAVASCULAR CATHETER

Catalog Number 391360

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the neoflon 24ga 0.7mm od 19mm l india the catheter was defective.There were ten occurrences.The following information was provided by the initial reporter: catheter tip of the cannula got pinctured / burst during first insertion into patients' vein.

Event Description

It was reported that during use of the neoflon 24ga 0.7mm od 19mm l india the catheter was defective.There were ten occurrences.The following information was provided by the initial reporter: catheter tip of the cannula got pinctured / burst during first insertion into patients' vein.

Manufacturer Narrative

Investigation: dhr was performed and no qn was raised or abnormality observed tha could have influenced the issue.1 photo was returned for investigation.4 used samples were observed from the returned photos, however, the nonconformance cannot be seen due to the photo being unclear.The complaint is unconfirmed as no sample is received.Based on similar complaint on peelback, the probably root cause could be due to tubing material and capa#81917 was issued to review the tubing material.

• Brand Name: NEOFLON 24GA 0.7MM OD 19MM L INDIA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8545376
• MDR Text Key: 145114267
• Report Number: 8041187-2019-00321
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 391360
• Device Lot Number: 8141428
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other