MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 20G X 10 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 20ga x 10 cm powerglide pro midline catheter assembly.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 split was observed just distal of the molded joint.Microscopic examination of the catheter split 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.The short time frame between the insertion date and the date of discovery suggests this damage likely occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of redp1096 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that powerglide has a tiny pinhole up where the hub connects onto the catheter.It was observed when the line was placed and when it was flushed, it squirted at the nurse.8/28/2019: additional information: nurse had to re-stick the patient to insert a new device.

• Brand Name: BASIC KIT 20G X 10 CM WITH GUARDIVA
• 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: 9082859
• Report Number: 3006260740-2019-02724
• Device Sequence Number: 2664612
• Product Code: FOZ
• UDI-Device Identifier: 00801741140488
• UDI-Public: (01)00801741140488
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120107T
• Device Lot Number: REDP1096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1