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

Catalog Number	381311
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.¿.
Additional 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 or Problem 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
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8401533
• Report Number: 8041187-2019-00212
• Device Sequence Number: 18937506
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8198135
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other