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

Catalog Number 0935280

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the syringe contained foreign material.

Manufacturer Narrative

Received 3 syringe bulb samples.During the visual inspection, it was noted that there was a black spot in every sample.The foreign material was measured, and the following results were found: sample 1: foreign material = 0.0625 in (specification is 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).Sample 2: foreign material = 0.0312 in (specification is 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).Sample 3: foreign material = 0.0625 in (specification is 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).In order to verify if the foreign material was embedded, the following task was performed: take a towel and wet it with alcohol.Wipe the barrel syringe with towel.During this task the foreign material could not be removed from the 3 samples.The foreign material is embedded.The samples were found within specification.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "irrigation syringe bulb type non sterile." (b)(4).

Event Description

It was reported that the syringe contained foreign material.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6561810
• MDR Text Key: 75146786
• Report Number: 1018233-2017-02388
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0935280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1