MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE PRO MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide catheter and guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged over the needle tip.The guidewire exhibited a compete break in the core wire.The coil wire was elongated but intact.The guidewire was inlaid through the catheter.The tip of the wire protruded from the end of the catheter.The weld tip was intact.The catheter exhibited a sharp bend approximately 2cm from the distal end.The wire protruded from a split at the bend site.Microscopic inspection of the sample confirmed that the coil wire and weld tip were intact.Inspection of the needle bevel revealed outward flaring mechanical damage along the proximal edge.The needle bevel damage was consistent with guidewire withdrawal against the needle bevel, likely initiating guidewire damage.Subsequent pulling appeared to have completed the break in the core wire and elongate the coil wire as the catheter was advanced.The usage residue suggested this occurred during attempted device placement.A lot history review (lhr) of recu1142 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that guidewire of midline threaded with no resistance, but catheter only threaded halfway before stopping entirely.There was no attempt to force catheter further.When attempting to withdrawal needle, there was resistance felt.The needle would not retract at all.The exterior case of the midline then split along the middle and needle retracted but guidewire did not.Catheter was removed and found to be damaged with guidewire still inside catheter.Ultrasound was used to search for any solid/foreign material left in patient's arm and none was found.A new midline catheter was successfully placed with no complications after malfunctioning midline was removed.Sterile field was not broken during event.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• 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: 8417672
• Report Number: 3006260740-2019-00551
• Device Sequence Number: 11319523
• Product Code: FOZ
• UDI-Device Identifier: 00801741110559
• UDI-Public: (01)00801741110559
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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: F118081
• Device Lot Number: RECU1142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1