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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JINRO PIGTAIL; TUBE, DRAINAGE, SUPRAPUBIC
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BOSTON SCIENTIFIC CORPORATION JINRO PIGTAIL; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Model Number M0064202020
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on an unknown date.According to the complainant, a cut was noted to the packaging of the device which compromised the sterility of the device.Reportedly, it is unknown if the cut was already present upon receipt of the device or if it was caused by an internal action.There was no patient or procedure involved.
 
Manufacturer Narrative
Block h6: problem code 2385 captures the reportable issue of packaging torn.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on an unknown date.According to the complainant, a cut was noted to the packaging of the device which compromised the sterility of the device.Reportedly, it is unknown if the cut was already present upon receipt of the device or if it was caused by an internal action.There was no patient or procedure involved.**additional information received on (b)(6) 2020** it was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on (b)(6) 2019.According to the complainant, it was noted that the cutter hit the shipping box.The primary packaging of the product was damaged making it unsterile.Reportedly, the damage was linked to the reception of the products.The package could not be opened without the help of a cutter.
 
Manufacturer Narrative
Additional information: block b5 (describe event or problem) block d4 (lot# and expiration date) block h10 block h6: problem code 2385 captures the reportable issue of packaging torn.Block h10: a visual examination of the returned packaging found that the device was returned in an unopened pouch.It was also noticed that the pouch was cut consequently confirming the reported allegation.The integrity of the package and the device inside the pouch were not compromised.This failure is likely due to factors or conditions related to procedure such as handling of the device during preparation, or storage could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on an unknown date.According to the complainant, a cut was noted to the packaging of the device which compromised the sterility of the device.Reportedly, it is unknown if the cut was already present upon receipt of the device or if it was caused by an internal action.There was no patient or procedure involved.**additional information received on (b)(6) 2020** it was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on (b)(6), 2019.According to the complainant, it was noted that the cutter hit the shipping box.The primary packaging of the product was damaged making it unsterile.Reportedly, the damage was linked to the reception of the products.The package could not be opened without the help of a cutter.
 
Event Description
It was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on an unknown date.According to the complainant, a cut was noted to the packaging of the device which compromised the sterility of the device.Reportedly, it is unknown if the cut was already present upon receipt of the device or if it was caused by an internal action.There was no patient or procedure involved.**additional information received on 08jan2020** it was reported to boston scientific corporation that a jinro pigtail nephrostomy set was unpacked on december 04, 2019.According to the complainant, it was noted that the cutter hit the shipping box.The primary packaging of the product was damaged making it unsterile.Reportedly, the damage was linked to the reception of the products.The package could not be opened without the help of a cutter.
 
Manufacturer Narrative
Block h6: problem code 2385 captures the reportable issue of packaging torn.Block h10: a visual examination of the returned packaging found that the device was returned in an unopened pouch.It was also noticed that the pouch was cut consequently confirming the reported allegation.The integrity of the package and the device inside the pouch were not compromised.This failure is likely due to factors or conditions related to procedure such as handling of the device during preparation, or storage could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.Block h11: correction: block h10.
 
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Brand Name
JINRO PIGTAIL
Type of Device
TUBE, DRAINAGE, SUPRAPUBIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9529767
MDR Text Key189877672
Report Number3005099803-2019-06283
Device Sequence Number1
Product Code FFA
Combination Product (y/n)N
PMA/PMN Number
K944290
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/25/2022
Device Model NumberM0064202020
Device Catalogue Number420-202
Device Lot Number0024498329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Date Manufacturer Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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