MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 IRRIG-BULK/CLEAN 100; ASEPTO BULBE SYRINGE

Model Number	0935280
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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 gnat inside an asepto bulbe syringe.
Event or Problem Description
It was reported that the gnat was inside an asepto bulbe syringe.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used irrigation bulb syringe.Visual inspection of the sample noted that there was a gnat, which was larger than 0.6 sq mm, within the barrel of the syringe.This does not meet the specification "loose or embedded foreign matter greater than 0.6mm2 or 1/16¿ in length is not permitted.(3 particles maximum per side or surface).Per tappi dirt estimation chart." per ip7600403, revision 9.A potential root cause for this failure could be ¿no follow up to the production areas cleaning procedure.¿ a review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.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 labelling could not have prevented the reported failure.The actual/suspected device was inspected.

• Brand Name: IRRIG-BULK/CLEAN 100
• Common Device Name: ASEPTO BULBE SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11942438
• Report Number: 1018233-2021-03254
• Device Sequence Number: 19924713
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 11/30/2025
• Device Model Number: 0935280
• Device Catalogue Number: 0935280
• Device Lot Number: NGEY0624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown