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

Catalog Number	0035830
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.¿ (b)(4).

• Brand Name: EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE
• Common Device Name: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7231787
• Report Number: 1018233-2018-00296
• Device Sequence Number: 13487962
• Product Code: KYZ
• UDI-Device Identifier: 00801741049286
• UDI-Public: (01)00801741049286
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0035830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1