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

Catalog Number 0035280

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 06/11/2018

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 user found foreign material, which appeared to be trash, in the syringe.The device was not used.

Event Description

It was reported that the user found foreign material, which appeared to be trash, in the syringe.The device was not used.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.Visual evaluation of the returned sample noted one opened, unused bulb syringe present.A small black particulate, resembling lint or detritus, measuring 0.1mm^2 was observed within the barrel of the syringe barrel.The presence of filth is considered out of specification, which states that no filth is allowed.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, 50cc this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Contains or presence of phthalates (dehp) contains or presence of phthalates: di(2-ethylhexyl)phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks single use do not resterilize.Do not use if package is damaged.Latex-free.Manufacturer.Sterilized using ethylene oxide.Caution, consult accompanying documents.Authorized representative in the european community.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.¿.

• 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 GA 30014
• MDR Report Key: 7664457
• MDR Text Key: 113454960
• Report Number: 1018233-2018-02624
• 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: 09/20/2018

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: 0035280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1