MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381244
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the insyte gn 18ga x 1.16in when pulling the catheter out part of the catheter sheared into the patient's leg and was unable to be removed.An xrays was taken of patient's leg and lungs, unable to remove piece surgically as it had already entered the patient's (a great dane) lung tissue.It is expected to scar over and have none to minimal impact on the patient.The following information was provided by the initial reporter: material no.: 381244, batch no.: 8110303.It was reported after pulling out the catheter part of the catheter sheared into the patient's leg and was unable to be removed.
Additional Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.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.H3 other text : see section h.10.
Event or Problem Description
It was reported that during use of the insyte gn 18ga x 1.16in when pulling the catheter out part of the catheter sheared into the patient's leg and was unable to be removed.An xrays was taken of patient's leg and lungs, unable to remove piece surgically as it had already entered the patient's (a great dane) lung tissue.It is expected to scar over and have none to minimal impact on the patient.The following information was provided by the initial reporter: material no.: 381244, batch no.: 8110303.It was reported after pulling out the catheter part of the catheter sheared into the patient's leg and was unable to be removed.

• Brand Name: INSYTE GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8679124
• Report Number: 8041187-2019-00434
• Device Sequence Number: 1876078
• Product Code: FOZ
• UDI-Device Identifier: 30382903812449
• UDI-Public: 30382903812449
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 07/10/2019

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 381244
• Device Lot Number: 8110303
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: Required Intervention