MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22G X 1.00IN (0.9 X 25 MM) INSYTE; INTRAVASCULAR CATHETER

Catalog Number 381223

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

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 during use of the 22g x 1.00in (0.9 x 25 mm) insyte the needle of the catheter passes through the silicone part the following information was provided by the initial reporter, translated from spanish to english: the metal needle of the catheter passes through the silicone part.

Manufacturer Narrative

Investigation: our quality engineer was unable to verify the reported complaint.Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process.

Event Description

It was reported that during use of the 22g x 1.00in (0.9 x 25 mm) insyte the needle of the catheter passes through the silicone part the following information was provided by the initial reporter, translated from spanish to english: the metal needle of the catheter passes through the silicone part.

• Brand Name: 22G X 1.00IN (0.9 X 25 MM) INSYTE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9224561
• MDR Text Key: 170301252
• Report Number: 8041187-2019-00842
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: 30382903812234
• 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: 11/14/2019

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: 07/31/2023
• Device Catalogue Number: 381223
• Device Lot Number: 8231379
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other