MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20G X 1.00IN (1.1 X 25 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number	381233
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 defective catheter tip was found with a 20g x 1.00in (1.1 x 25 mm) insyte.The following information was provided by the initial reporter."the problem we were encountering is that the catheters were not advancing correctly and burring in the patient.We attempted multiple times and it continued to happen, all catheters were from the same lot.Products were not samples issued, i order boxes of 50 at a time." 1 of 2 complaints.
Additional Manufacturer Narrative
The additional information is as follows: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8300598.Medical device expiration date: 2023-10-31.Device manufacture date: 2018-10-27.Medical device lot #: 8234048 medical device expiration date: 2023-08-31.Device manufacture date: 2018-08-22.
Event or Problem Description
It was reported that defective catheter tip was found with a 20g x 1.00in (1.1 x 25 mm) insyte.The following information was provided by the initial reporter, "the problem we were encountering is that the catheters were not advancing correctly and burring in the patient.We attempted multiple times and it continued to happen, all catheters were from the same lot.Products were not samples issued, i order boxes of 50 at a time." 1 of 2 complaints.
Event or Problem Description
It was reported that defective catheter tip was found with a 20g x 1.00in (1.1 x 25 mm) insyte.The following information was provided by the initial reporter, "the problem we were encountering is that the catheters were not advancing correctly and burring in the patient.We attempted multiple times and it continued to happen, all catheters were from the same lot.Products were not samples issued, i order boxes of 50 at a time." 1 of 2 complaints.
Additional Manufacturer Narrative
Investigation summary: 45 representative samples were returned for investigation.A quality engineer inspected the returned units and could not identify any manufacturing related defects or abnormalities.Tip of the catheter was observed for catheter tip integrity.No catheter tip integrity was observed.The samples were subjected to cannula penetration test.All the representative samples passed the cannula penetration test.A device history record review was performed and showed no non-conformances associated with this issue during the production of these batches.As a result, the root cause of the reported issue could not be determined.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: 20G X 1.00IN (1.1 X 25 MM) INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8678671
• Report Number: 8041187-2019-00431
• Device Sequence Number: 14018353
• Product Code: FOZ
• UDI-Device Identifier: 30382903812333
• UDI-Public: 30382903812333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2019

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: 10/31/2023
• Device Catalogue Number: 381233
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019; 05/21/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/23/2019; 08/01/2019
• 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