MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HYDROSIL GO INTERMITTENT URINARY CATHETER; INTERMITTENT CATHETER

Model Number	71814
Medical Device Problem Codes	Component Missing (2306); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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 probe was missing from the blister pack during a demonstration.They had only the cup and not yet able to check others like that in the box.
Additional Manufacturer Narrative
The reported event is confirmed - manufacturing related.Visual evaluation noted one photo sample received.Visual inspection noted photo sample contained one magic3go handle and packaging.No silicone catheter is evident in photo sample received.Although an exact root cause could not be established, a potential root cause is operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the probe was missing from the blister pack during a demonstration.They had only the cup and not yet able to check others like that in the box.

• Brand Name: HYDROSIL GO INTERMITTENT URINARY CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11584751
• Report Number: 1018233-2021-01697
• Device Sequence Number: 14220993
• Product Code: EZD
• UDI-Device Identifier: 00801741098017
• UDI-Public: (01)00801741098017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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 Expiration Date: 06/30/2022
• Device Model Number: 71814
• Device Catalogue Number: 71814
• Device Lot Number: JUDT0133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other