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

Catalog Number	0035830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
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.The device was not returned.
Event or Problem Description
It was reported the patient was undergoing a lumpectomy.The bulb syringe was opened during the case and a small piece of green plastic matching the green plastic of the bulb came out of the bulb when it was being used to irrigate.The piece was removed from the surgical field.
Event or Problem Description
It was reported the patient was undergoing a lumpectomy.The bulb syringe was opened during the case and a small piece of green plastic matching the green plastic of the bulb came out of the bulb when it was being used to irrigate.The piece was removed from the surgical field.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿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.Single use 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.Do not use if package is damaged.Manufacturer caution, consult accompanying documents.Use by units latex free sterilized using ethylene oxide authorized representative in the european community lot number catalog number 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.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.".

• Brand Name: EAR/ULCER SYRINGE, PVC-FLEX 3 OZ. (GREEN), STERILE
• Common Device Name: BULB IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7468870
• Report Number: 1018233-2018-01373
• Device Sequence Number: 1233460
• Product Code: KYZ
• UDI-Device Identifier: 00801741049286
• UDI-Public: (01)00801741049286
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 0035830
• Device Lot Number: NGBU0223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1