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

Catalog Number 0035280

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2019

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 (hair) was inside the bulb irrigation syringe.

Event Description

It was reported that foreign material (hair) was inside the bulb irrigation syringe.

Manufacturer Narrative

The reported event was confirmed as cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), bulb syringe.Visual inspection of the sample noted a loose hair between the bulb and syringe on the outside.This product is out of specification as per the standard which states that "no hair on product is permitted".Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be "no follow up to production areas cleaning procedure".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual." product catalog number 0035280 is deemed by appropriate subject matter experts (sme) to be within this definition.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
• Type of Device: BULB IRRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8776439
• MDR Text Key: 150616546
• Report Number: 1018233-2019-03811
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 0035280
• Device Lot Number: NGCX2666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1