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

Catalog Number	F320108PT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaulation.
Event or Problem Description
It was reported by customer that the rn inserted the powerglide midline.Initially had a good blood return but unable to flush.Confirmed tip placement using ultrasound machine.The rn stated that she was able to visualize the tip inside the vessel but unable to flush the catheter.Midline catheter was removed.She assessed the catheter and noticed a kinked.No other information was provided.
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 a kinked catheter is confirmed and was determined to be use related.One catheter from a 20 ga powerglide pro was returned for evaluation.An initial visual observation showed blood use residues throughout the returned catheter.A slight kink was observed at the proximal end of the catheter and towards the middle of the catheter.A functional test of attempting to infuse water into the catheter using a 12 ml syringe revealed the catheter was patent to infusion with no observed resistance.Because the event description states difficulty infusing into the catheter due to a kink during use, the complaint of a catheter kink is confirmed and was determined to be use related.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by customer that the rn inserted the powerglide midline.Initially had a good blood return but unable to flush.Confirmed tip placement using ultrasound machine.The rn stated that she was able to visualize the tip inside the vessel but unable to flush the catheter.Midline catheter was removed.She assessed the catheter and noticed a kinked.No other information was provided.

• Brand Name: FULL KIT 20G X 10 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19100140
• Report Number: 3006260740-2024-01720
• Device Sequence Number: 12579812
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/23/2024

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: 11/30/2024
• Device Catalogue Number: F320108PT
• Device Lot Number: REHW3007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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