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

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2018

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.The device was not returned.

Event 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 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.

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
• Type of Device: BULB IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7468870
• MDR Text Key: 106859607
• Report Number: 1018233-2018-01373
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049286
• UDI-Public: (01)00801741049286
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 0035830
• Device Lot Number: NGBU0223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1