MAUDE Adverse Event Report: FINE SURGICAL INSTRUMENTS CIRCUMCISION CLAMP, SIZE 1.3CM; CLAMP, CIRCUMCISION

Catalog Number 32-1622

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

The circumcision clamps the customer got from us were packaged with malformed bells with chips and dings in them.

Manufacturer Narrative

Investigation findings: when the report was received, the qfi report was reviewed to obtain the sales and similar complaint info.Deroyal has sold (b)(4) cases of the finished good from 2012 to 2014.Similar reports were received from previous customer complaints and subsequent inventory evals.The finished good and lot number were reviewed to and raw material (b)(4), lot # 1160146 was identified.The product was supplied to deroyal by (b)(4) instrument supplies.The vendor was previously notified of issues with the identified lot number.The vendor has responded with a letter.Refer to the (b)(4) supplier letter attachment.Due to the previously identified issues with the product, deroyal initiated a recall for all finished good devices that contained the identified raw material and lot number.Correction: replacements have been provided.Root cause analysis: vendor: the root cause was determined to be mfg related issues on behalf of the supplier due to negligence of the qc, final inspection, and packaging personnel.Deroyal: (b)(4)- the clamps were purchased from a secondary vendor due to back order issue from the current supplier and were made to their specifications and not to deroyal's specifications.The (b)(4) personnel responsible for ordering parts failed to detect this issue, and when the part went on back order from the current supplier and the decision was made to have the buyers purchase the item from (b)(4).The qc personnel responsible for the incoming inspection failed to detect the clamps did not meet the specification.This was an oversight.Qc inspected the part through a visual inspection and was under the impression the missing pvc washer was not part of the design for the new supplier.

• Brand Name: CIRCUMCISION CLAMP, SIZE 1.3CM
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): FINE SURGICAL INSTRUMENTS; sialkot ; PK
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 3983103
• MDR Text Key: 4815945
• Report Number: 2320762-2014-00012
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Catalogue Number: 32-1622
• Device Lot Number: 33423747
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 300040625-01/27/2014-001
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention