MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER; MAGIC 3 CATHETER

Catalog Number	50810G
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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 the patient said he folded the packaging and it did not go back to straight and it hurt him.No medical intervention reported.Per follow up received on 9apr2020, the customer stated that he placed the catheter in his pocket and when he took it out he noticed that the catheter was bent.In addition the customer stated he received 50812g catheters that were different diameters and unable to be used and the end was thin.
Event or Problem Description
It was reported that the patient said he folded the packaging and it did not go back to straight and it hurt him.No medical intervention reported.Per follow up received on 9apr2020, the customer stated that he placed the catheter in his pocket and when he took it out he noticed that the catheter was bent.In addition the customer stated he received 50812g catheters that were different diameters and unable to be used and the end was thin.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "operator error".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "inspect the catheter before use.Do not use the product if the device or packaging is damaged.".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.

• Brand Name: MAGIC3 GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9944476
• Report Number: 1018233-2020-02484
• Device Sequence Number: 19542012
• Product Code: EZD
• UDI-Device Identifier: 00801741137006
• UDI-Public: (01)00801741137006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: Lay User/Patient
• Device Catalogue Number: 50810G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1