MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SYRINGE IRRIGATION BULK / CLEAN, 50ML; BULB SYRINGE

Catalog Number 0935280

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the scrub tech was setting up on the table, patient noticed an insect inside the asepto bulb syringe which came in the double basin pack.Setup was considered contaminated and was taken down and implant tray needed to be reprocessed which caused a delay in the case.Surgeon was notified as well as administration.Patient was never brought into room.

Event Description

It was reported that the scrub tech was setting up on the table, patient noticed an insect inside the asepto bulb syringe which came in the double basin pack.Setup was considered contaminated and was taken down and implant tray needed to be reprocessed which caused a delay in the case.Surgeon was notified as well as administration.Patient was never brought into room.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was not used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), unused irrigation bulb syringe.Visual inspection of the sample noted that there was no foreign material within the syringe or the bag that the syringe was received in.This met the specification "loose foreign matter was not permitted in excess of a total aggregate of 0.6mm2.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.A labeling review was not performed because 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 actual/suspected device was inspected.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: BULB SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11321656
• MDR Text Key: 231621732
• Report Number: 1018233-2021-00467
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0935280
• Device Lot Number: NGET3175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other