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

Catalog Number 2283

Device Problems Loss of or Failure to Bond (1068); Nonstandard Device (1420); Product Quality Problem (1506); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); 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.The device was not returned.

Event Description

It was reported that the wife advised that some of sheaths in the previous box lot no jucz0137 were faulty.The glue was too weak.She also advised that others were too sticky and hard to remove.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿too much adhesive¿.A potential root cause for this failure could be "operator error".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: ¿to remove: the sheath may be removed by gently rolling it off the penis.Avoid simply pulling the sheath off.Removing the sheath whilst having a bath or shower may increase comfort." 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 device was not returned.

Event Description

It was reported that the wife advised that some of sheaths in the previous box lot no jucz0137 were faulty.The glue was too weak.She also advised that others were too sticky and hard to remove.

• Brand Name: ROCHESTER CLEAR ADVANTAGE WITH ALOE SHORT SHEATH
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8796040
• MDR Text Key: 151299968
• Report Number: 1018233-2019-03955
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: 2283
• Device Lot Number: JUCZ0137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1