MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MID-STREAM URINE COLLECTOR

Model Number	842904
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
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 customer had one case of defective midstream where the glue was not keeping the item sealed.Per follow up on (b)(6) 2021, customer stated product box lid that was glued to keep the product sealed was not holding.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.2 samples were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted 2 opened (with original packaging), unused mid stream urine collection kits were received.Visual inspection of the 2 cardboard boxes were unsealed upon receipt.One of the return sample had hardened glue where the flap is supposed to attach and one with the glue on the flap with no evidence on the packaging that it was ever attached.There appears to be no evidence or damage that the flap was ever sealed onto the carton for either sample.This does not meet the specification "the unit box shall be glued square.Maximum out of line is 3/16".Zipper flaps shall be folded and glued such that the zipper is not prematurely started.".A potential root cause for this failure could be ¿incorrect gluing".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.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 labelling could not have prevented the reported failure.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the customer had one case of defective midstream where the glue was not keeping the item sealed.Per follow up on 26may2021, customer stated product box lid that was glued to keep the product sealed was not holding.

• Brand Name: MID-STREAM URINE COLLECTOR
• Common Device Name: MID-STREAM URINE COLLECTOR
• 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: 12024685
• Report Number: 1018233-2021-03606
• Device Sequence Number: 17210649
• Product Code: FMH
• UDI-Device Identifier: 00801741051227
• UDI-Public: (01)00801741051227
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: 10/31/2025
• Device Model Number: 842904
• Device Catalogue Number: 842904
• Device Lot Number: NGEX2247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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