MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24G X 0.56IN (0.7 X 14 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number 381311

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Tissue Damage (2104)

Event Date 02/19/2019

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 the 24g x 0.56in (0.7 x 14 mm) insyte experienced foreign matter contamination.The customer reported, "there is resistance when infusing with these catheters, it is impossible to instal it into the vein.When removing the catheter, a piece of plastic i visible coming off the system (at the end of the catheter).The consequences for the patient are deterioration of the vein and multiple infusions required.¿.

Manufacturer Narrative

Investigation: 20 samples without unit package were returned for investigation (not decontaminated).The returned samples were subjected to visual inspection.No defective/damaged catheter and no fm were observed the returned samples.The returned samples were subjected to penetration test.All the samples meet the test requirement.The complaint cannot be confirmed as no defect was observed on the returned samples and the samples passed penetration test.The product is within the specification.The complaint cannot be confirmed as no abnormality was observed on the returned samples.Hence, there is no assignable root cause.Dhr review was performed and no related qn was raised.

Event Description

It was reported that the 24g x 0.56in (0.7 x 14 mm) insyte experienced foreign matter contamination.The customer reported, "there is resistance when infusing with these catheters, it is impossible to instal it into the vein.When removing the catheter, a piece of plastic i visible coming off the system (at the end of the catheter).The consequences for the patient are deterioration of the vein and multiple infusions required.¿.

• Brand Name: 24G X 0.56IN (0.7 X 14 MM) INSYTE
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8401533
• MDR Text Key: 138383949
• Report Number: 8041187-2019-00212
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8198135
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other