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

Catalog Number 0935280

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); 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.

Event Description

It was reported that there was mold found in the syringe prior to use.

Event Description

It was reported that there was mold found in the syringe prior to use.

Manufacturer Narrative

The reported event was confirmed as cause unknown.The visual evaluation of the returned sample noted one opened (without original packaging) irrigation bulb syringe with 5 dark brown particles within the syringe between the barrel and the bulb.It was noted that the largest speck had an area of 1.5 sq mm.Foreign materials with a total aggregate area of larger than 0.6 sq mm are considered out of specification.The lot number is unknown; therefore, the device history record could not be reviewed.21 cfr 801.116 outlines the conditions upon which a device is exempt from adequate directions as follows: "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 0935280 was deemed by appropriate subject matter experts (sme) to be within this definition.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: ASEPTO SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8311191
• MDR Text Key: 135504701
• Report Number: 1018233-2019-00661
• 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,user facili
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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 Catalogue Number: 0935280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1