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

Catalog Number 0035280

Device Problems Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

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

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that green foreign material came out of the inside of the syringe during use.

Event Description

It was reported that green foreign material came out of the inside of the syringe during use.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened bulb irrigation syringes in the original packaging.A green silicone substance (0.7615in long) found outside the syringe.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿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: 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.".

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Type of Device: BULB SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8083117
• MDR Text Key: 127560917
• Report Number: 1018233-2018-05510
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 0035280
• Device Lot Number: NGCS2581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2018
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1