MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recn2839 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient had accucath placed in arm, while it was already in arm, the catheter broke off into patient's arm and could not be identified in the vein under ultrasound.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged accucath catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 18ga x 2.25" accucath peripheral iv catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a break was observed just distal of the luer adapter.Microscopic examination of the catheter break confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The location of the damage suggested that site maintenance technique may have contributed.The product ifu states ¿avoid accidental device contact with sharp instruments¿.A lot history review (lhr) of recn2839 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient had accucath placed in arm, while it was already in arm, the catheter broke off into patient's arm and could not be identified in the vein under ultrasound.No other information was provided.

• Brand Name: ACCUCATH, 18 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8675759
• Report Number: 3006260740-2019-01566
• Device Sequence Number: 2220440
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Model Number: N/A
• Device Catalogue Number: AC0182250
• Device Lot Number: RECN2839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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