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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE; BULB IRRIGATION SYRINGE
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C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE; BULB IRRIGATION SYRINGE Back to Search Results
Catalog Number 0035280
Device Problems Break (1069); Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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: "¿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.¿" (b)(4).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 that as a doctor was creating a skin pocket for the insertion of a pacemaker and irrigating the new "pocket", he noticed a 2 to 2.5 cm long, very thin, sliver of green plastic sitting in the bottom of the pocket.It appeared to be from the bottom edge of the green bulb which sits inside the syringe portion of the bulb syringe device.Analysis of the device at the facility by looking through the clear plastic of the syringe portion showed a neck edge of the green bulb was not smooth.Part of the bulb still had a rough edge remaining and attached.It appears that the selvage edge at the neck of the bulb was where the green sliver broke off.It appeared that "the sliver which broke off seems to be a byproduct of the manufacturing process." there was no harm to the patient and the sliver was quickly removed.
 
Event Description
It was reported that as a doctor was creating a skin pocket for the insertion of a pacemaker and irrigating the new "pocket", he noticed a 2 to 2.5 cm long, very thin, sliver of green plastic sitting in the bottom of the pocket.It appeared to be from the bottom edge of the green bulb which sits inside the syringe portion of the bulb syringe device.Analysis of the device at the facility by looking through the clear plastic of the syringe portion showed a neck edge of the green bulb was not smooth.Part of the bulb still had a rough edge remaining and attached.It appears that the selvage edge at the neck of the bulb was where the green sliver broke off.It appeared that "the sliver which broke off seems to be a byproduct of the manufacturing process." there was no harm to the patient and the sliver was quickly removed.
 
Manufacturer Narrative
The complaint was confirmed, as other related issue.During the visual inspection of the pictures a green plastic inside of the container was noticed.The green plastic piece was part of the bulb.The following capa ng-capa(b)(4), and scar cc-sc-122017-003 have been submitted in order to address the molding issues for component cm1893 (green bulb).The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state 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." corrections: concomitant medical products and device evaluated by mfr.
 
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Brand Name
BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
Type of Device
BULB IRRIGATION SYRINGE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7298827
MDR Text Key101249735
Report Number1018233-2018-00579
Device Sequence Number1
Product Code KYZ
UDI-Device Identifier00801741049255
UDI-Public(01)00801741049255
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0035280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Initial Date Manufacturer Received 02/05/2018
Initial Date FDA Received02/27/2018
Supplement Dates Manufacturer Received04/30/2018
Supplement Dates FDA Received05/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age85 YR
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