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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer the line was inserted around 1447 without issue and was functioning well when iv team member left the patient.At approximately 1730 nursing team noted bleeding at site of iv insertion of skin.Iv flushed and + blood return.Coag patch applied over insertion site and tegaderm applied.At change of shift patient with oozing diluted bloody fluid.Infusion was stopped.Site undressed and staff found fluid bubbling out of actual iv insertion site catheter where angio catheter connects into the plastic hub.Additional information received 12 february 2024: there was no harm to the patient.Patient was a difficult access and piv was placed to replace the midline.
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 evaluation.
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 a 20 ga x 10 cm powerglide pro was returned for evaluation.An initial visual observation showed blood use residues throughout the returned catheter.The powerglide pro catheter was returned with extension tubing, a needleless injection cap, and a statlock stabilization device attached to its luer.A circumferentially aligned split was observed just distal of the luer of the catheter.A microscopic observation revealed granular fracture surface and sharp fracture edges of the split in the catheter.The observed characteristics of the split are typically initiated by pulling the catheter back against the needle bevel during the insertion process.The complaint of a split in the catheter is confirmed and was determined to be use related.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer the line was inserted around 1447 without issue and was functioning well when iv team member left the patient.At approximately 1730 nursing team noted bleeding at site of iv insertion of skin.Iv flushed and + blood return.Coag patch applied over insertion site and tegaderm applied.At change of shift patient with oozing diluted bloody fluid.Infusion was stopped.Site undressed and staff found fluid bubbling out of actual iv insertion site catheter where angio catheter connects into the plastic hub.Additional information received 12 february 2024: there was no harm to the patient.Patient was a difficult access and piv was placed to replace the midline.

• 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: 18846976
• Report Number: 3006260740-2024-00931
• Device Sequence Number: 7814697
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: F320108PT
• Device Lot Number: REHS1545
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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