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

Model Number M118101

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

Event Type  malfunction  

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 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
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7614778
• MDR Text Key: 112001689
• Report Number: 3006260740-2018-01437
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741038112
• UDI-Public: (01)00801741038112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1