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

Model Number	M118101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
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 following were reviewed as part of this investigation: patient severity, frequency 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 an hub detachment is confirmed but the exact cause is unknown.Two photo samples of a powerglide catheter and extension set were returned for evaluation.An initial visual observation of the photos revealed the distal end of the extension tubing detached from the male luer connector.A ring of adhesive appears to be visible near the detached end.Based on the description of the reported event and photo samples provided, possible contributing factors include excessive tensile force and insufficient adhesive bonding.The complaint of a detached hub is confirmed but the exact cause could not be determined with the photo samples provided.A lot history review (lhr) of rebv0884 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the tubing of the extension set came apart from the hub connected to the powerglide catheter.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL 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: 7614778
• Report Number: 3006260740-2018-01437
• Device Sequence Number: 13497287
• Product Code: FOZ
• UDI-Device Identifier: 00801741038112
• UDI-Public: (01)00801741038112
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: M118101
• Device Catalogue Number: M118101
• Device Lot Number: REBV0884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1