MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MIDSTREAM CATCH KIT

Model Number	842803
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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 glue that keeps the midstream boxes closed was not glued shut and the midstream fell to the ground.
Event or Problem Description
It was reported that glue that keeps the midstream boxes closed was not glued shut and the midstream fell to the ground.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for treatment purposes.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), mid-stream urine collector cardboard box received unsealed upon return.There was hardened glue present on one side of the cardboard box where the flap is supposed to attached, and there was no evidence to support that the flap has ever been sealed.A potential root cause for this failure could be incorrect gluing.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.

• Brand Name: MIDSTREAM CATCH KIT
• Common Device Name: MIDSTREAM CATCH KIT
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12071112
• Report Number: 1018233-2021-03813
• Device Sequence Number: 4004284
• Product Code: FMH
• UDI-Device Identifier: 00801741051210
• UDI-Public: (01)00801741051210
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 842803
• Device Catalogue Number: 842803
• Device Lot Number: NGFP2270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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