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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6 PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6 PADDIE, COTTONOID Back to Search Results
Catalog Number 24-5431
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 09/07/2017
Event Type  malfunction  
Manufacturer Narrative
The corrective action was to check the manufacturing documentation for this lot and perform a tcr for all the operators associated with the lot under question. The manufacturing documentation was pulled and reviewed. Nothing was found to be out of the ordinary with this work order. Root cause is likely due to operator error, this however could not be determined. Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack. The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack. A tcr and ilc were opened to retrain all the operators that had worked on this product and lot #.
 
Event Description
As reported by the distributor, a 10-pk of surgery strips contained 9. No reported patient harm or delay reported.
 
Manufacturer Narrative
The corrective action was to check the manufacturing documentation for this lot and perform a tcr for all the operators associated with the lot under question. The manufacturing documentation was pulled and reviewed. Nothing was found to be out of the ordinary with this work order. Root cause is likely due to operator error, this however could not be determined. Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack. The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack. A tcr and ilc were opened to retrain all the operators that had worked on this product and lot #.
 
Event Description
As reported by the distributor, a 10-pk of surgery strips contained 9. No reported patient harm or delay reported.
 
Manufacturer Narrative
(b)(4). It has been communicated that the device is not available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
 
Event Description
As reported by the distributor, a 10-pk of surgery strips contained 9.
 
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Brand NameBULK SURG STRIP 1/4 X 6
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6906762
MDR Text Key247570544
Report Number1226348-2017-10720
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5431
Device Lot NumberC62788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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