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 07/18/2018

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 there was black foreign material on the syringe when the user opened the package.It is unknown whether the foreign material is internal or external to the device.

Event Description

It was reported that there was black foreign material on the syringe when the user opened the package.It is unknown whether the foreign material is internal or external to the device.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened, unused bulb irrigation syringe.Visual inspection of the package noted a portion of the material discolored near the tip of the syringe.The discoloration measured approximately 0.0625" in length and appeared to be embedded throughout the material, as if the pvc had been exposed to high temperatures and decomposed.Micro-scale pictures were taken to better observe the nature of the discoloration.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: ¿irrigation syringe - bulb type, 50cc 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 (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 manufacturer sterilized using ethylene oxide caution, consult accompanying documents authorized representative in the european community 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: 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: 7777684
• MDR Text Key: 117014528
• Report Number: 1018233-2018-03532
• 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: 10/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 0035280
• Device Lot Number: NGBW0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 10/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1