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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC
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ETHICON INC. PROLENE SUTURE 36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number D7768
Medical Device Problem Code Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
 
Event or Problem Description
It was reported during an unknown cardiovascular surgery on (b)(6) 2018 a suture was prepared for use in the operating room.The needle-suture in question was not used on the patient.The surgeon requested manufacturer investigate if there is a pin hole on the package of the needle suture there were no adverse consequences to the patient.
 
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Brand Name
PROLENE SUTURE 36"(90CM) 4-0 BLU
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7671052
Report Number2210968-2018-74184
Device Sequence Number906529
Product Code GAW
UDI-Device Identifier10705031028357
UDI-Public10705031028357
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133356
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/11/2018
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 Health Professional
Device Expiration Date11/30/2022
Device Catalogue NumberD7768
Device Lot NumberLPJ672
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/11/2018
Initial Report FDA Received Date07/09/2018
Patient Sequence Number1
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