MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that tubing separated from the needleless connector end and wound-up causing blood to reflux in the line and rendered the line unusable.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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of tubing disconnection from the luer adapter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a powerglide pro extension set.The sample was placed within a plastic bag.Possible biological or infusate residue was visible within the clear tubing.A needleless injection cap was attached to the luer adapter.The tubing was completely detached or broken from the luer adapter.Inspection of the photograph was insufficient to determine if the tubing became detached or fractured, nor could the root cause of the damage be identified.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.
Event or Problem Description
It was reported by customer that tubing separated from the needleless connector end and wound-up causing blood to reflux in the line and rendered the line unusable.No other information was provided.

• Brand Name: FULL KIT 20G X 8 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18094299
• Report Number: 3006260740-2023-05069
• Device Sequence Number: 17831220
• Product Code: FOZ
• UDI-Device Identifier: 00801741140624
• UDI-Public: (01)00801741140624
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/14/2024

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: REHU1888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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