MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported, "product broken." no other information was provided.Additional information provided 03/15/2024: it was reported, "in patient vessel when failure happened.While placing under ultrasound, guidewire was advanced (without difficulty) and when advancing catheter, it was not able to advance.Catheter retracted to check for tip placement.Guidewire retracted as well.Tip placement confirmed.Guidewire re-advanced without difficulty.When re-advancing catheter the same issue was noted.When removing catheter and needle as a failed attempt, it had to be pulled/forced out (like a barb) to be able to remove the needle from the patients arm.".
Event or Problem Description
It was reported, "product broken".No other information was provided.Additional information provided on 03/15/2024: it was reported, "in patient vessel when failure happened.While placing under ultrasound, guidewire was advanced (without difficulty) and when advancing catheter, it was not able to advance.Catheter retracted to check for tip placement.Guidewire retracted as well.Tip placement confirmed.Guidewire re-advanced without difficulty.When re-advancing catheter the same issue was noted.When removing catheter and needle as a failed attempt, it had to be pulled/forced out (like a barb) to be able to remove the needle from the patients arm".
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 complaint of difficult catheter insertion resulting in catheter damage was confirmed but the cause is unknown.A single photograph of the implicated powerglide catheter was returned for evaluation.The guidewire push-off button and catheter wings were in the non-advanced position on the deployment device.It was difficult to discern from the photograph the exact location of the guidewire as it appeared there were two dark wire-like objects: one which was bent to the side of the needle and appeared to protrude through the flash groove in the needle cannula and another that appeared to protrude from the distal end of the catheter.It is unknown which object is the guidewire or if the guidewire contained damage causing the coil and core wire to separate.The catheter was still on the deployment device but had been damaged.It appeared that the catheter had either been perforated or split, allowing it to feed off of the needle at an angle.A high-resolution view of the catheter damage was not provided, so the features of the damage could not be discerned.Possible contributing factors for the difficult insertion could include insertion technique, product dimensions, advancement of the catheter against resistance, or reinsertion of the needle.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.
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 complaint of difficult catheter advancement was confirmed and found to be use related.The product returned for evaluation was one 20g powerglide pro device.A gross visual inspection of the returned device found that the catheter tubing was pierced through by the needle.Blood residue was observed throughout the device indicating that the reported event occurred during use.Additionally, a portion of the guidewire was threaded through the catheter which indicated that the spear through occurred during or after the catheter was being threaded over the guidewire.Microscopic inspection of the catheter found that a second v-shaped tear was present distal of the spear through location.A needle spear through may occur in the clinician setting if the needle is advanced at a wrong angle or if the needle is moved up and down the catheter tubing.
Event or Problem Description
It was reported, "product broken." no other information was provided.Additional information provided 03/15/2024: it was reported, "in patient vessel when failure happened.While placing under ultrasound, guidewire was advanced (without difficulty) and when advancing catheter, it was not able to advance.Catheter retracted to check for tip placement.Guidewire retracted as well.Tip placement confirmed.Guidewire re-advanced without difficulty.When re-advancing catheter the same issue was noted.When removing catheter and needle as a failed attempt, it had to be pulled/forced out (like a barb) to be able to remove the needle from the patients arm.".

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19015471
• Report Number: 3006260740-2024-01388
• Device Sequence Number: 20817995
• Product Code: FOZ
• UDI-Device Identifier: 00801741140679
• UDI-Public: (01)00801741140679(11)230905(17)240930(10)REHU1209
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 09/17/2024

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F320088PT
• Device Lot Number: REHU1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 09/17/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/16/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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