MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA URETHRAL CATHETER TRAY, CLEAR PLASTIC CATHETER; JELLY

Model Number	802214
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the customer had about 5 trays that were missing either the catheter or the jelly pack.It was later reported that the customer experienced 2 additional failures with the trays.One was missing the jelly packet and the other had an extra jelly pack.
Event or Problem Description
It was reported that the customer had about 5 trays that were missing either the catheter or the jelly pack.It was later reported that the customer experienced 2 additional failures with the trays.One was missing the jelly packet and the other had an extra jelly pack.
Additional Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿missing components." it was unknown whether the device had met specifications.The product was not used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The labelling review was not performed because the labelling could not have prevented the reported failure.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.

• Brand Name: BARDIA URETHRAL CATHETER TRAY, CLEAR PLASTIC CATHETER
• Common Device Name: JELLY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10403519
• Report Number: 1018233-2020-05154
• Device Sequence Number: 11536601
• Product Code: KOD
• UDI-Device Identifier: 00801741018404
• UDI-Public: (01)00801741018404
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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 Model Number: 802214
• Device Catalogue Number: 802214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1