MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE; EAR AND ULCER SYRINGE

Model Number	0035820
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2020
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 foreign material was found in device.
Additional Manufacturer Narrative
The reported event was confirmed, as a manufacturing-related.Visual evaluation of the returned sample noted two unopened (inside original packaging), ear and ulcer syringes were received.Visual inspection of the sample noted two pieces of cardboard-like paper material (measuring 1.80 sq mm and 1.50 sq mm) loose on the syringes inside the package.Also, a black foreign material was much larger than 0.6 mm was found in the package.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to a "defective/ contaminated components from the supplier." the devices did not meet the specifications, and was influenced by the reported failure.The product used for the treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed because the labeling 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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the foreign material was found in device.

• Brand Name: EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE
• Common Device Name: EAR AND ULCER SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10712537
• Report Number: 1018233-2020-20272
• Device Sequence Number: 11633536
• Product Code: KYZ
• UDI-Device Identifier: 00801741049279
• UDI-Public: (01)00801741049279
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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 Expiration Date: 12/31/2024
• Device Model Number: 0035820
• Device Catalogue Number: 0035820
• Device Lot Number: NGDZ0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other