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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. X-STREAM TUBING SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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DAVOL INC., SUB. C.R. BARD, INC. X-STREAM TUBING SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 5552002
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The subject product was not returned; however, a photo was provided.Review of the photo was not helpful in determining the source of the alleged foreign material.The area of concern was circled with a marker by the customer, however, there was nothing that could be seen in the photo to indicate hair/foreign material within the packaging.Based on not having the sample returned to evaluate, 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.Should additional information be provided a supplemental emdr will be submitted.Not returned.
 
Event Description
It was reported that during a warehouse inspection at the hospital, a hair-like foreign material was observed inside the x-stream tubing set w/nd trumpet valve packages.There was no patient involvement as the reported product issue was discovered during inspection.
 
Event Description
It was reported that during a warehouse inspection at the hospital, a hair-like foreign material was observed inside the x-stream tubing set w/nd trumpet valve packages.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.Review of the photo was not helpful in determining the source of the alleged foreign material.The area of concern was circled with a marker by the customer, however, there was nothing that could be seen in the photo to indicate hair/foreign material within the packaging.Based on not having the sample returned to evaluate, 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: h11: this is an addendum to the initial emdr.This supplemental emdr is submitted to report the corrected additional event information (h.10) section.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 previously submitted initial and supplemental emdrs to document the receipt and evaluation of the sample.The subject device was returned for evaluation.Visual evaluation of the sample showed that no foreign material was identified at either of the circles drawn onto the blister tray on the outside or inside.There was no damage to the blister tray, tyvek lid or the tubing set and no foreign material was noted.The previously provided photo shows a mark inside of the red circle that is not present at this time.It is possible that this was on the outside of the blister tray and no longer presenting due to subsequent handling of the product.Based on the sample evaluation and investigation performed, the reported event is unconfirmed for foreign material.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.
 
Event Description
It was reported that during a warehouse inspection at the hospital, a hair-like foreign material was observed inside the x-stream tubing set w/nd trumpet valve packages.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.Review of the photo was not helpful in determining the source of the alleged foreign material.The area of concern was circled with a marker by the customer, however, there was nothing that could be seen in the photo to indicate hair/foreign material within the packaging.Based on not having the sample returned to evaluate, 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.Should additional information be provided a supplemental emdr will be submitted.Addendum: h11: this is an addendum to the initial emdr.This supplemental emdr is submitted to report the corrected additional event information (h.10) section.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.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.
 
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Brand Name
X-STREAM TUBING SETS
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key10372362
MDR Text Key201905093
Report Number1213643-2020-07148
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00801741010095
UDI-Public(01)00801741010095
Combination Product (y/n)N
PMA/PMN Number
K003790
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 Expiration Date03/28/2022
Device Catalogue Number5552002
Device Lot NumberJUDRF148
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
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