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

Catalog Number	0035280
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
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 inside the package.Per additional information received via email on 24 march 2020 from ibc representative, the foreign material was found inside the syringe.
Event or Problem Description
It was reported that foreign material was found inside the package.Per additional information received via email on 24 march 2020 from ibc representative, the foreign material was found inside the syringe.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one unopened bulb syringe received.Visual evaluation noted a brown cardboard like substance measuring 4.00 sp mm was found inside the syringe body of the unopened packaging.This is out of specification per the standard, which states, "loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per tappi dirt estimation chart." although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be defective/ contaminated components from supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because the user alleged the presence of foreign material on the product, which the user did not cause.Labeling does not apply in this case.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: 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 GA 30014
• MDR Report Key: 9958200
• Report Number: 1018233-2020-02578
• Device Sequence Number: 11448299
• 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: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 0035280
• Device Lot Number: NGDT3381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1