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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that they placed powerglide into vein when preparing to secure device to skin noticed bleeding from site attempted to flush midline with normal saline and noticed the saline was leaking from the site as well.Inspected the catheter and noticed leaking from the catheter-hub junction.The device was removed from patient.Patient was left without iv access.And required another stick.Additional information received on 02-sep-2023: when attempting to secure the catheter with the statlock the site was leaking blood, when the hub was lifted slightly it became worse, placer was instructed to remove the device.When removed and flushed there was a small hole in the device where the catheter when flushing.Another device had to be inserted and required an additional stick for the patient this was not an urgent situation.The product was discarded because of contamination with blood.
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that they placed powerglide into vein when preparing to secure device to skin noticed bleeding from site attempted to flush midline with normal saline and noticed the saline was leaking from the site as well.Inspected the catheter and noticed leaking from the catheter-hub junction.The device was removed from patient.Patient was left without iv access.And required another stick.Additional information received on 02-sep-2023: when attempting to secure the catheter with the statlock the site was leaking blood, when the hub was lifted slightly it became worse, placer was instructed to remove the device.When removed and flushed there was a small hole in the device where the catheter when flushing.Another device had to be inserted and required an additional stick for the patient this was not an urgent situation.The product was discarded because of contamination with blood.
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.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed; however, the root cause could not be determined.One photograph and one video of a powerglide pro catheter was returned for evaluation.An initial visual observation of the photograph showed a syringe attached to the catheter.Evidence of a leak could be seen on the cloth beneath the catheter.An initial visual observation of the video showed the catheter being flushed.The device was leaking at the junction of the pink molded joint and the catheter tubing.Use residue was observed on the sample in the returned photograph and video.No other details of the damage were observed on the sample in the returned photograph and video.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17764476
• Report Number: 3006260740-2023-04144
• Device Sequence Number: 6618325
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/10/2024

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: F320108PT
• Device Lot Number: REGZ0614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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