MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 18G X 10 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "powerglide fell apart.It seems to be more of an issue when placing in more superficial vessels rather than deeper ones.Most likely due to the angle and pressure applied when advancing (leap frogging) into the vein.It causes it to split and open up like a space shuttle launching to the moon.Pieces falling off and breaking apart the further it travels.May just be operator error.Experienced the issue with the kit.No patient harm, just makes insertion difficult.".
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refy1478 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "powerglide fell apart.It seems to be more of an issue when placing in more superficial vessels rather than deeper ones.Most likely due to the angle and pressure applied when advancing (leap frogging) into the vein.It causes it to split and open up like a space shuttle launching to the moon.Pieces falling off and breaking apart the further it travels.May just be operator error.Experienced the issue with the kit.No patient harm, just makes insertion difficult.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of separation of the deployment device housing was inconclusive due to the sample condition.A series of six photographs of a powerglide pro deployment device and catheter were returned for evaluation.Only the distal end of the deployment device and part of the catheter were within the frame of the photographs.The top and bottom pieces of the deployment device housing were starting to separate, and the catheter was seen protruding from the side of the deployment device.The guidewire was not seen protruding from the distal end of the catheter and the guidewire push-off button did not appear to be in the fully advanced location.The housing is designed to separate as the catheter is advanced to allow for passage of the luer adaptor and wings off of the deployment device.It could not be determined from the photographs if the insertion sequence was followed or if the housing separated prematurely during the procedure.Without functional testing of the physical device, it could not be determined if the device failed to perform as intended.However, the report of a difficult insertion has been documented and included in complaint trending as part of ongoing efforts to identify potential issues.H3 other text : evaluation findings are in section h.11.

• Brand Name: BASIC KIT 18G X 10 CM WITH GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15736362
• Report Number: 3006260740-2022-04293
• Device Sequence Number: 14199022
• Product Code: FOZ
• UDI-Device Identifier: 00801741140464
• UDI-Public: (01)00801741140464
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/06/2022

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: F118107T
• Device Lot Number: REFY1478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown