MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

It was reported "i placed a powerglide and when the catheter was advanced and guidewire retracted i noticed the guidewire was a small fraction of the length it normally is, leading me to believe the guidewire may have broken off in the vessel.After further inspection i opened the device and could clearly see the guidewire was intact but had retracted into the shaft of the device.No patient harm.".

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refw2667 showed no other similar product complaint(s) from this lot number.

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of guidewire difficulty was confirmed.The product returned for evaluation was one 20ga powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism was engaged over the needle tip.The guidewire was fully extended, but was not engaged with the guidewire advancer.The guidewire was bent at the exit site from the needle tip.The guidewire did not move during manipulation of the advancer because of that disengagement.Following disassembly, microscopic inspection of the guidewire advancer revealed wear marks in the coupler region.Both the wear marks on the coupler and the advanced position of the guidewire suggested that the guidewire was initially assembled correctly with the advancer and became subsequently dislodged.Such dislodgement can occur if guidewire advancement is attempted against resistance, such as into tissue.The blood residue suggested that dislodgement likely occurred during attempted device placement.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported "i placed a powerglide and when the catheter was advanced and guidewire retracted i noticed the guidewire was a small fraction of the length it normally is, leading me to believe the guidewire may have broken off in the vessel.After further inspection i opened the device and could clearly see the guidewire was intact but had retracted into the shaft of the device.No patient harm.".

• Brand Name: FULL KIT 20G X 10 CM WITH PROBE COVER
• Type of Device: 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: 13904684
• MDR Text Key: 288018451
• Report Number: 3006260740-2022-00974
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140631
• UDI-Public: (01)00801741140631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F220108PT
• Device Lot Number: REFW2667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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
• Patient Outcome(s): Other