Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SOFT SPLASH SHIELD WITH SHOWERHEAD TIP; LAVAGE, JET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. SOFT SPLASH SHIELD WITH SHOWERHEAD TIP; LAVAGE, JET Back to Search Results
Catalog Number 0057730
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 to date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in december, 2019.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 soft splash shield w/showerhead tip, simpulse plus 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 to date, this is the only reported complaint from this manufacturing lot of 360 units released for distribution in december, 2019.If/when additional information is provided, a supplemental emdr will be submitted.Addendum: this is an addendum to the initial emdr.This supplemental emdr is submitted to report the corrected investigation findings.Based on the investigation activities performed, the reported event was confirmed.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.If/when additional information is provided, a supplemental emdr will be submitted.
 
Event Description
It was reported that during inspection at the hospital warehouse, an unknown particulate was observed inside the soft splash shield w/showerhead tip, simpulse plus package.There was no patient involvement as the reported product issue was discovered during inspection.
 
Event Description
It was reported that during inspection at the hospital warehouse, an unknown particulate was observed inside the soft splash shield w/showerhead tip, simpulse plus 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 to date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in december, 2019.Addendum: h11: this is an addendum to the initial emdr.This supplemental emdr is submitted to report the corrected investigation findings.Based on the investigation activities performed, the reported event was confirmed.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.Addendum: this is an addendum to the previous initial and supplemental emdrs submitted to document the receipt and results of the sample evaluation.The subject product was returned for evaluation.The product returned matches that of the previously provided photo.Visual evaluation of the returned sample showed a small gray foreign particulate within the sealed product packaging as reported.The foreign matter is of unknown origin.As the packages are sealed with the foreign matter inside, the root cause of the reported issue is confirmed for a manufacturing related issue.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOFT SPLASH SHIELD WITH SHOWERHEAD TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key10372466
MDR Text Key201872818
Report Number1213643-2020-07152
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00801741010422
UDI-Public(01)00801741010422
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,Followup
Report Date 09/25/2020
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 Number0057730
Device Lot NumberJUDY1830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-