MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON 26GA 0.6MM OD 19MM L INDIA; IV CATHETER

Catalog Number 391359

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, a supplemental report will be filed.

Event Description

It was reported that ten neoflon 26ga 0.6mm od 19mm l india experienced a defect with the cannula of the device malfunctioning.The following information was provided by the initial reporter: catheter tip of the cannula got punctured / burst during first insertion into patients' vein.

Manufacturer Narrative

Investigation: dhr was reviewed, no qn was raised and no abnormality observed that could have influenced the issue for the batch.1 photo and 1 used sample were returned for investigation.4 used samples were observed from the returned photo, however, the nonconformance reported cannot be seen due to photo not clear.The 1 used sample was subjected to visual inspection.Peelback was observed on the 1 used sample.The complaint is confirmed and product is out of specification.Based on similar complaint on peelback, the probably root cause could be due to tubing material.Capa#81917 was issued to review the tubing material.

Event Description

It was reported that ten neoflon 26ga 0.6mm od 19mm l india experienced a defect with the cannula of the device malfunctioning.The following information was provided by the initial reporter: catheter tip of of the cannula got pinctured / burst during first insertion into patients' vein.

• Brand Name: NEOFLON 26GA 0.6MM OD 19MM L INDIA
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8519482
• MDR Text Key: 145665281
• Report Number: 8041187-2019-00307
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 391359
• Device Lot Number: 7354023
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other