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

Catalog Number 0035280

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

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 black colored dust was found as the package was opened.It is unknown whether the dust was found inside or outside the device.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (within unsealed original packaging), un-used bulb irrigation syringe present.No foreign material was noted within the packaging or the exterior of the syringe.A small (0.4mm^2) embedded black particle was observed on the bulb of the syringe.However, the size of the particle was deemed acceptable, as the specification stated loose or embedded foreign material shall not exceed aggregate total of 0.6mm^2.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state 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.¿.

Event Description

It was reported that black colored dust was found as the package was opened.It was unknown whether the dust was found inside or outside the device.

• 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: 7566266
• MDR Text Key: 110175703
• Report Number: 1018233-2018-02024
• 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: 08/30/2018

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 0035280
• Device Lot Number: NGBZ1875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 08/26/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1