MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC LAPAROSCOPY D AND C PACK (LSJHR)497; CURETTE, UTERINE

Model Number	SMA11LSJH3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that the clear balloon portion of the 18 french foley catheter, 87-605189, from a laparoscopy dilation and curettage pack, sma11lsjh3, came apart from the catheter and was found in the patient¿s bladder.The piece was found when a routine cystoscopy was done at the end of the procedure.The intact piece was removed.The patient is doing fine with no problems.
Additional Manufacturer Narrative
Photos of the affected sample were provided for review and show that the balloon broke from the catheter.One used sample was also received for evaluation.Visual evaluation was performed, and it was determined that the balloon had broken, however when the sample was received at the manufacturing site the balloon piece was not received just the catheter.Based on the information provided the most probable root cause could be related to damage of the bushings used in the molding process which then may cause imperfections and results in a burst balloon condition.The following actions have been implemented by the manufacturing site; replacement of the damaged bushings as well all involved personnel were alerted of the issue reported.We will continue to monitor trends for this product.

• Brand Name: LAPAROSCOPY D AND C PACK (LSJHR)497
• Common Device Name: CURETTE, UTERINE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood dr; waukegan IL 60085
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14881029
• Report Number: 1423537-2022-00795
• Device Sequence Number: 14743187
• Product Code: HCY
• UDI-Device Identifier: 10195594635237
• UDI-Public: 10195594635237
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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 Model Number: SMA11LSJH3
• Device Catalogue Number: SMA11LSJH3
• Device Lot Number: 811639
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 80 KG