MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PVC EXTENSION TUBING

Model Number	4A4194
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the pvc extension tubing was kinking up when the patient was sleeping and it caused the catheter to come loose so it caused leakage.
Event or Problem Description
It was reported that the pvc extension tubing was kinking up when the patient was sleeping and it caused the catheter to come loose so it caused leakage.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "incorrect assembly operation of tube coiling (incorrect assembly)¿.It was unknown whether the device had met specifications.It was unknown whether the product had caused the reported failure.A device history record review could not be performed without a lot number.A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared.Hence labelling review is not required.The information provided by bd represents all 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.

• Brand Name: PVC EXTENSION TUBING
• Common Device Name: PVC EXTENSION TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15745148
• Report Number: 1018233-2022-08518
• Device Sequence Number: 5851056
• Product Code: FAQ
• UDI-Device Identifier: 00801741051562
• UDI-Public: (01)00801741051562
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: Lay User/Patient
• Device Model Number: 4A4194
• Device Catalogue Number: 4A4194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 03/11/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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