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

Model Number 0035280

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

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

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 foreign material was found inside the syringe.

Event Description

It was reported that foreign material was found inside the syringe.Per follow up via ibc on 18mar2021, the issue was found upon opening of the package.

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 not used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone irrigation bulb syringe.Visual inspection of the sample noted no obvious visible defects.It was noted that there was a loose piece of cardboard material on the interior of the syringe barrel.This does not meet product specifications.A potential root cause for this failure could be "no following to production areas cleaning procedure".The dhr review could not be performed without a lot number.A labeling review was not performed because labelling could not have prevented the reported failure.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 evaluated.

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11604206
• MDR Text Key: 243546294
• Report Number: 1018233-2021-01777
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049255
• UDI-Public: (01)00801741049255
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0035280
• Device Catalogue Number: 0035280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other