MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURG. SUCTION/IRRIGATION; SYRINGE

Device Problem 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 the syringe had a small amount of dirt on the inside near the outlet.

Event Description

It was reported that the syringe had a small amount of dirt on the inside near the outlet.

Manufacturer Narrative

The reported event was confirmed as cause unknown.Visual evaluation of the photo sample noted one opened (without original packaging), unknown irrigation syringe.Visual inspection of the photo sample noted a bug inside of the irrigation syringe.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be ¿defective /contaminated components from supplier¿.The lot number is unknown therefore the device history record could not be reviewed.The product family for this surg.Suction/irrigation product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the surg.Suction/irrigation product labeling are found to be adequate based on past reviews.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: SURG. SUCTION/IRRIGATION
• Type of Device: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8794459
• MDR Text Key: 151284605
• Report Number: 1018233-2019-03943
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1