MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE; IRRIGATION SYRINGE

Catalog Number 0035830

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

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2018

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 a green colored foreign material came out of the syringe.Two syringes were used, but the user was unable to identify which syringe the material came from.The syringes were not used on the patient.

Manufacturer Narrative

The reported event was confirmed as supplier related.During the visual evaluation of the returned syringes, there were no manufacturing discrepancies found.A green colored loose material that was stuck with tape was found.The green colored loose material was evaluated and found that it was of the same material with which the syringe is manufactured.No voids, distortions or missing parts of the syringes were observed.The foreign material was measured, and found to be 0.0805".(specification is loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per tappi dirt estimation chart.).The foreign material exceeded the current specification.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: ¿ear and ulcer syringe with slim tip for aspiration and irrigation, 1 oz.This is a single use device.Do not resterilize any portion of this device.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 warning: 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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.¿.

Event Description

It was reported that a green colored foreign material came out of the syringe.Two syringes were used, but the user was unable to identify which syringe the material came from.The syringes were not used on the patient.

• Brand Name: EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE
• 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: 7231278
• MDR Text Key: 98846390
• Report Number: 1018233-2018-00288
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049286
• UDI-Public: (01)00801741049286
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0035830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2018
• 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