MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MUCOUS SPECIMEN TRAP, 40ML, STERILE

Catalog Number	0035860
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that the mucus trap had different markings.It was noted that on one product below the 10ml, there were 3 lines marked and on another product, there were only 2 lines that were marked.
Event or Problem Description
It was reported that the mucus trap had different markings.It was noted that on one product below the 10ml, there were 3 lines marked and on another product, there were only 2 lines that were marked.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted 2 photo samples were received showing two mucous traps.Visual evaluation noted one of the devices has 2 markings under the 10ml mark and the other device has 3 markings under the 10ml mark.Both of these devices are confirmed failures stating assembly must conform to print.Figure 1 shows 4 markings below the 10ml mark.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be ribbon exhausted.The lot number was unknown; therefore, the device history record could not be reviewed.The "instructions for use" were found adequate and state the following: ¿directions: 1.Tighten cap to seal mucous specimen trap before using.2.Attach female connector to suction instrument or catheter.3.Attach male connector to suction source.4.Obtain specimen.5.Disconnect trap and fully secure female connector over male connector on cap.6.Attach patient identification label to vial (not supplied).Assembled in mexico.Caution, consult accompanying documents.Single use.Do not resterilize.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: MUCOUS SPECIMEN TRAP, 40ML, STERILE
• Common Device Name: MUCOUS SPECIMEN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10200046
• Report Number: 1018233-2020-04103
• Device Sequence Number: 14270524
• Product Code: GCY
• UDI-Device Identifier: 00801741049293
• UDI-Public: (01)00801741049293
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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 Catalogue Number: 0035860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1