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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SIMPULSE PLUS SUCTION IRRIGATOR TIP; LAVAGE, JET
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DAVOL INC., SUB. C.R. BARD, INC. SIMPULSE PLUS SUCTION IRRIGATOR TIP; LAVAGE, JET Back to Search Results
Catalog Number 0057621
Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The subject product was not returned; however, a photo was provided.Photo evaluation confirms the presence of an unidentified particulate within the package.Review of the photo was not helpful in determining the source of the foreign material.A determination of what the foreign material is cannot be made without the sample to evaluate, as such, no conclusion can be made.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.If/when additional information is provided, a supplemental emdr will be submitted.Not returned - sample unavailable.
 
Event Description
It was reported that during inspection at the hospital warehouse, an unknown particulate was observed inside the simpulse plus showerhead tip suction irrigator package.There was no patient involvement as the reported product issue was discovered during inspection.
 
Manufacturer Narrative
The subject product was not returned; however, a photo was provided.Photo evaluation confirms the presence of an unidentified particulate within the package.Review of the photo was not helpful in determining the source of the foreign material.A determination of what the foreign material is cannot be made without the sample to evaluate, as such, no conclusion can be made.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.Addendum: h.11: this is an addendum to the initial emdr.This supplemental emdr was submitted to report the corrected investigation findings.Based on the investigation activities performed, the reported event was confirmed.Although the provided photos confirm for foreign matter inside the sealed packages, the origin of the foreign matter could not be determined.However, as the foreign matter was present in the package prior to sealing, this presented at the time of manufacturing and is confirmed for a manufacturing related condition.Awareness training was provided to appropriate associates.Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned - sample unavailable.
 
Event Description
It was reported that during inspection at the hospital warehouse, an unknown particulate was observed inside the simpulse plus showerhead tip suction irrigator package.There was no patient involvement as the reported product issue was discovered during inspection.
 
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Brand Name
SIMPULSE PLUS SUCTION IRRIGATOR TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key10372555
MDR Text Key201872290
Report Number1213643-2020-07154
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00801741010415
UDI-Public(01)00801741010415
Combination Product (y/n)N
PMA/PMN Number
K830386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0057621
Device Lot NumberJUDUF033
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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