MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE

Model Number	0035280
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
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 the customer found prior to opening a package, that there was a foreign material inside it.Per follow up with the ibc via email on 17nov2020, we could not obtain the detail information of the place the foreign material was found.
Event or Problem Description
It was reported that upon opening a package the customer found a foreign material inside the package.Per follow up with the ibc via email on (b)(6) 2020 it was stated that the customer could not obtain the detailed information of the place where the foreign material was found.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one unopened irrigation bulb syringe was received.Visual evaluation noted that there was a green fiber like loose piece of foreign material measuring 0.1095 inches found on the inside of the syringe barrel on return.A potential root cause for this failure mode was unable to determine.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Per investigation a labeling review was not required.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.

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Common Device Name: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10951519
• Report Number: 1018233-2020-21395
• Device Sequence Number: 16849035
• Product Code: KYZ
• UDI-Device Identifier: 00801741049255
• UDI-Public: (01)00801741049255
• 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): 04/14/2021

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: 01/31/2025
• Device Model Number: 0035280
• Device Catalogue Number: 0035280
• Device Lot Number: NGEN4059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 05/06/2021
• 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