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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2024
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 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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that bedside nurse noticed some leaking around iv site during assessment.Picc nurse noticed that iv catheter is completely severed from the hub.Md ordered removal of retained catheter via interventional radiology (ir).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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported that bedside nurse noticed some leaking around iv site during assessment.Picc nurse noticed that iv catheter is completely severed from the hub.Md ordered removal of retained catheter via interventional radiology (ir).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 split in the catheter is confirmed and was determined to be use-related.One catheter from an 18 ga powerglide pro attached to extension tubing was returned for evaluation.An initial visual observation showed blood use residues throughout the returned powerglide pro catheter.A circumferentially aligned split was observed just distal of the green luer at a kink in the tubing.A microscopic observation revealed an overall elliptical shape of the catheter at the split site.The split was observed to have a granular fracture surface along one side of the break site and a shiny, reflective fracture surface on the side of the break site that pulled apart during microscopic observation of the device.The catheter broke completely during microscopic observations.One edge of the break site appeared to have ¿c¿ shaped impressions leading to the split site.Observations of the returned catheter appeared to align with damage caused by flexural fatigue, or cyclic kinking of the catheter.Additionally, the damage location suggested that catheter securement, access and maintenance techniques may have contributed to the failure.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that bedside nurse noticed some leaking around iv site during assessment.Picc nurse noticed that iv catheter is completely severed from the hub.Md ordered removal of retained catheter via interventional radiology (ir).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.
Event or Problem Description
It was reported via medwatch: midline to right-upper arm leaking.Upon examination, the catheter was found to be half sheared/cracked) at base.Lactated ringers infusion, continuous iv fluid replacement therapy.

• Brand Name: FULL KIT 18G 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19536887
• Report Number: 3006260740-2024-03016
• Device Sequence Number: 14995430
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662(11)240129(17)250131(10)REHY3257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F318108PT
• Device Lot Number: REHY3257
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 08/19/2024; 11/25/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/27/2024; 08/23/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Unknown