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

Model Number 0935280

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2021

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 syringe appeared to have fluid in it.

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), unused bulb irrigation syringe.Visual inspection of the sample noted that there was unknown fluid in the barrel of the syringe.This does not meet the specification "no grease or oil is permitted." 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.A labeling review was not performed because labelling could not have prevented the reported failure.Correction: d,h h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the syringe appeared to have some fluid in it.

• 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: 11305453
• MDR Text Key: 231112358
• Report Number: 1018233-2021-00383
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0935280
• Device Catalogue Number: 0935280
• Device Lot Number: NGEW0458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other