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	03/30/2021
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.The device was not returned.
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 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 as manufacturing related.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted 1 box (with original packaging), received with 100 catheters each.A sampling plan was conducted.Visual inspection of the sample noted all boxes had glue that was completely hardened on one side of the cardboard box, with no evidence that the flaps had ever been sealed.The product was considered as out of specification.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.The instructions for use were found adequate and state the following: "instructions for use (male) sterile - interiors of protective collar and specimen container are sterile unless collar and container are opened or damaged.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.1.Grasp white lid by tab and lift to remove 2.Place white lid on flat surface with specimen cap face up.3.Open packet of three towelettes.4.Retract foreskin if present 5.With the first towelette, cleanse the meatal orifice with a single downward stroke.Discard towelette.6.Repeat step 5 with the two remaining towelettes 7.First void in toilet.As you continue to void, bring urine collector (holding it by the handle) into ¿midstream¿ to collect urine specimen.8.Unscrew protective collar from specimen container and discard.9.Without touching specimen container cap, pick up white funnel lid and screw cap onto specimen container.10.Remove the white lid from cap by lifting up tab.11.Fill in complete information on label and attach to specimen container." h11:section a through f - the information provided by bd represents all of 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 glue closing the outer box was not staying sealed in two cases of midstream clean catch.The nurses feel that the inner contents had been compromised with the lid being opened.Further reported same issues on 18-mar-2021, 29-mar-2021and 09-apr-2021.Per follow-up response on 23apr2021 that two cases of midstream clean catheter product was returned on 23april2021 using labels provided.

• 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
• 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: 11718551
• Report Number: 1018233-2021-02355
• Device Sequence Number: 11804131
• 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): 10/25/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 11/15/2021
• 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