MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE WITH ALOE STANDARD M; MEC

Catalog Number 1283

Device Problems Leak/Splash (1354); Nonstandard Device (1420)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the sheaths were not staying on the patient which caused leaks.Per additional information from the investigator via email 16sep2019; while investigating the lot samples one mec tested for strong adhesive.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation noted 5 unopened clear advantage mec with aloe 28mm mecs were received.No obvious defects were noted and further testing was required.The adhesive peel test was performed per procedure and the samples were tested according to the general inspection level ii/single sampling plan.The samples were cut to the required width (0.70" +/- 0.05").The adhesive peel strength was found to be out of specification (0.60-2.10lbf) for one sample tested.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be mechanical failure.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: "the sheath is a strapless penile sheath: it has an adhesive coating inside to ensure a safe and simple procedure for fitting.¿ if necessary trim pubic hair.¿ clean and dry pubic area.¿ remove sheath from its wrapping.¿ place rolled end over the end of the penis, leaving a small space between the end of the penis and the cup of the sheath.If uncircumcised, do not retract the foreskin but allow it to remain over the glans.Avoid contact between the adhesive and the glans.¿ slowly unroll the sheath along the shaft of the penis, then gently squeeze the sheath around the penis to ensure even adhesion.Try to avoid leaving a rolled `collar´ of sheath around the base of the penis.¿ finally, connect the urine collection bag.Always check that the connections are secure before use.¿ wear time will vary from user to user.It is recommended that a sheath be changed every 24 hours for reasons of hygiene." 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.

Event Description

It was reported that the sheaths were not staying on the patient which caused leaks.Per additional information from the investigator via email 16sep2019; while investigating the lot samples one mec tested for strong adhesive.

• Brand Name: ROCHESTER CLEAR ADVANTAGE WITH ALOE STANDARD M
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9165857
• MDR Text Key: 179498344
• Report Number: 1018233-2019-06299
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 1283
• Device Lot Number: JUBU0533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1