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

Model Number	842904
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	03/23/2021
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 upon two cases of the midstream clean catch, the glue closing the outer box was not staying sealed and the lid was being opened.The nurse feels that the inner content had been compromised.Per follow up on 19apr2021, the customer noted that the glue on the inner box with the contents is not staying adhered so when they open the case, the individual boxes are wide open.Per customer via phone on 19apr2021, all known information regarding the event has been reported and no additional information is available at this time.
Additional Manufacturer Narrative
The reported event was confirmed - manufacturing related.Visual inspection noted 95 mid-stream urine collection devices were received.Visual evaluation noted 19 of the samples evaluated had the glue dried with the flap of the unit box packaging not adhered down.There also no evidence on the back side of the packaging that the flap was ever glued properly.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.
Event or Problem Description
It was reported that upon two cases of the midstream clean catch, the glue closing the outer box was not staying sealed and the lid was being opened.The nurse feels that the inner content had been compromised.Per follow up on (b)(6) 2021, the customer noted that the glue on the inner box with the contents is not staying adhered so when they open the case, the individual boxes are wide open.Per customer via phone on (b)(6) 2021, all known information regarding the event has been reported and no additional information is available at this time.

• Brand Name: MIDSTREAM URINE COLLECTOR
• Common Device Name: MIDSTREAM URINE COLLECTOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11693094
• Report Number: 1018233-2021-02208
• Device Sequence Number: 3085310
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 05/24/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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