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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2017
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility¿s registered nurse (rn) reported that a needle dislodged during hemodialysis (hd) therapy.The following details were provided.The needle dislodged from the cannulation site.The needle was replaced.The patient was able to complete treatment on the same machine.The estimated blood loss (ebl) was approximately 100 milliliters (ml).There was no patient adverse effect and no medical intervention required as a result of the event.The patient¿s post treatment condition was fine.The bloodlines were not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
 
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
FMC BLOODLINE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX   88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6848282
MDR Text Key85123654
Report Number8030665-2017-00661
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/27/2017
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
Device Operator Nurse
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age MO
Initial Date Manufacturer Received 08/16/2017
Initial Date FDA Received09/07/2017
Supplement Dates Manufacturer Received10/05/2017
Supplement Dates FDA Received10/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
JMS FISTULA NEEDLE
Patient Age75 YR
Patient Weight69
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