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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 135 S-PLK X SP NO LOGO SYRINGE, PISTON

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COVIDIEN 135 S-PLK X SP NO LOGO SYRINGE, PISTON Back to Search Results
Model Number 8881135019
Device Problems Break (1069); Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.   if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.   as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
The customer reported that during incoming inspection, the additional sampling confirmed that few syringes had damaged tip. There was no patient involved.
 
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Brand Name135 S-PLK X SP NO LOGO
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key11968295
MDR Text Key255364258
Report Number1915484-2021-01255
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881135019
Device Catalogue Number8881135019
Device Lot Number002088
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
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?
Type of Device Usage

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