MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPIRIT® HYDROCOLLOID ADHESIVE SHEATH; MALE EXTERNAL CATHETER

Catalog Number 35303

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2022

Event Type  Injury  

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 product catalog number of the male external catheter was the same as before, but the color of the writing on the inside packs had changed from blue to tan.It was stated that because of this change, they had been experiencing severe penile dermatitis and skin irritation.The user wondered if anything had changed in the manufacture of these items.The nurse stated that the patient had recently been subscribed with steroids by the general physician.Per additional information received on 10mar2022, it was reported that the general practitioner has recommended steroid cream and the patient was thankful having received samples of the same hollister product and was now back using inview.Also, the customer indicated that the allergy to inview had improved using the usual standard box (samples), it appeared that the patient allergy has improved and continued to use the product.

Event Description

It was reported that the product catalog number of the male external catheter was the same as before, but the color of the writing on the inside packs had changed from blue to tan.It was stated that because of this change, they had been experiencing severe penile dermatitis and skin irritation.The user wondered if anything had changed in the manufacture of these items.The nurse stated that the patient had recently been subscribed with steroids by the general physician.Per additional information received on 10mar2022, it was reported that the general practitioner has recommended steroid cream and the patient was thankful having received samples of the same hollister product and was now back using inview.Also, the customer indicated that the allergy to inview had improved using the usual standard box(samples), it appeared that the patient allergy has improved and continued to use the product.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.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: "warnings : reuse of a single use product may create potential risk to the user such as poor adhesion, leakage, and skin irritation.Precautions : do not use on irritated or compromised skin.Do not use if allergic reaction occurs.Ensure proper fit as instructed.If the sheath (catheter) size is incorrect or leakage occurs, skin damage may occur (e.G., irritation, broken skin, rash, or redness).This may decrease wear time.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Notes : contact a healthcare practitioner for help with the product or with skin irritation.In case of serious injury (incident) in relation to your use of the product, please contact your local distributor or manufacturer, and your local competent authority." correction: a, e.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 device was not returned.

• Brand Name: SPIRIT® HYDROCOLLOID ADHESIVE SHEATH
• Type of Device: MALE EXTERNAL CATHETER
• 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: 13925550
• MDR Text Key: 288030061
• Report Number: 1018233-2022-01645
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 35303
• Device Lot Number: JUFS9091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2022
• Event Location: Other
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male