MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM INTERMEDIATE KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120081
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recq0391 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after placement, the midline had kinked internally and was causing pain.The device was subsequently removed.No patient injury was reported.
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 kinked powerglide catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide midline catheter.The sample was received attached to an extension set.Usage residues were observed throughout the sample.A permanent kink impression was observed 2.8cm from the distal tip of the catheter.Tactile inspection of the sample confirmed the presence of a permanent kink.Microscopic inspection of the distal end of the sample revealed buckling near the distal tip of the catheter.The tip of the catheter exhibited discoloration and deformation.The compressed and buckled tip of the catheter suggested that difficulty was experienced during catheter insertion.The kink in the tubing was consistent with device manipulation during that apparent insertion difficulty.A lot history review (lhr) of recq0391 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after placement, the midline had kinked internally and was causing pain.The device was subsequently removed.No patient injury was reported.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM INTERMEDIATE KIT
• 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: 7674299
• Report Number: 3006260740-2018-01659
• Device Sequence Number: 1384390
• Product Code: FOZ
• UDI-Device Identifier: 00801741110573
• UDI-Public: (01)00801741110573
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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: F120081
• Device Catalogue Number: F120081
• Device Lot Number: RECQ0391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1