MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SOFT SPLASH SHIELD WITH SHOWERHEAD TIP; LAVAGE, JET

Catalog Number	0057730
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: SOFT SPLASH SHIELD WITH SHOWERHEAD TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10372466
• Report Number: 1213643-2020-07152
• Device Sequence Number: 19564480
• Product Code: FQH
• UDI-Device Identifier: 00801741010422
• UDI-Public: (01)00801741010422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K830386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2020

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: Other
• Device Expiration Date: 10/28/2024
• Device Catalogue Number: 0057730
• Device Lot Number: JUDY1830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 09/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/20/2020; 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1