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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported by customer that powerglide was easily placed but upon attaching ext set and flushing the device blood sprayed everywhere out from the catheter.There seems to be a hole on the catheter just before the catheter hub.The patient impact was that the patient had to be unnecessarily stuck a second time to place a different catheter that was not defective.There was no injury to the patient.No blood exposure to the nurse, it sprayed on the patient only 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 leak in the catheter was confirmed.The product returned for evaluation was one 20 ga powerglide pro.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument, likely the integrated introducer needle.The returned product sample was evaluated and a hole in the catheter was observed towards just distal of the catheter luer.Microscopic examination of the catheter hole confirmed it was typical of contact with a needle, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on the bevel of a needle.The fracture edges were sharply formed and had planar (flat) surfaces the damage also contained the overall shape of a chevron 'v'.This shape is common to many needle bevels, and this shape is often transferred onto the catheter when punctured by a needle pulling the catheter back along the needle shaft during attempted insertion may cause a split in the catheter from the needle bevel.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that powerglide was easily placed but upon attaching ext set and flushing the device blood sprayed everywhere out from the catheter.There seems to be a hole on the catheter just before the catheter hub.The patient impact was that the patient had to be unnecessarily stuck a second time to place a different catheter that was not defective.There was no injury to the patient.No blood exposure to the nurse, it sprayed on the patient only no other information was provided.

• Brand Name: FULL KIT 20G X 10 CM WITH 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: 20261482
• Report Number: 3006260740-2024-05319
• Device Sequence Number: 8931047
• Product Code: FOZ
• UDI-Device Identifier: 00801741140631
• UDI-Public: (01)00801741140631(11)240612(17)250630(10)REJR1391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/22/2024

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F220108PT
• Device Lot Number: REJR1391
• 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: 08/25/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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 Age: 84 YR
• Patient Sex: Male