MAUDE Adverse Event Report: CORDIS DE MEXICO EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

Catalog Number EX700CE

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2014

Event Type  malfunction  

Event Description

The report received from the affiliate indicated that during a warehouse inspection of the labeling process, the inner pouch of the 7 fr.Exoseal vascular closure device (vcd) was found to be open on one side.The product sterility was affected.(b)(4).The actual product had no damage.There were no anomalies noted except for this failure.The product had been already in this condition when it was delivered.The product was handled and stored as per the usual procedure.It was not shipped out of the j&j warehouse and was not clinically used.There was no reported patient injury.The product was neither re-sterilized nor re-packaged.The picture of the failure point was uploaded.The product will be returned for analysis.No additional information is available.

Manufacturer Narrative

The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

During a warehouse inspection of the labeling process, the inner pouch of the 7 fr.Exoseal vascular closure device (vcd) was found to be open on one side.The product sterility was affected.There was no reported patient injury.The product was one of one hundred ten products received with this lot number.The product was handled and stored as per the usual procedure.There were no anomalies noted except for this failure.It was not shipped out of the j&j warehouse and was not clinically used.The product was neither re-sterilized nor re-packaged.The actual product had no damage.The product was already in this condition when it was delivered.No additional information is available.One non sterile 7f exoseal was received inside a plastic bag in original packaging.The pouch was found unsealed (missing straight seal).No seal marks were found on pouch.The device was not used.The deployment lever was not depressed.The indicator window was received in black and white position.The guard was not depressed.The plug was received in the delivery shaft.The indicator wire was not deployed.No other anomalies were observed in the returned device.Review of lot 16009010 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported complaint was confirmed as a manufacturing related issue.The failure ¿packaging/pouch/box compromised sterility-seal open¿ reported by the customer was confirmed since the pouch was found unsealed (missing straight seal).A risk assessment has been initiated to evaluate this issue.

• Brand Name: EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
• Type of Device: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3838142
• MDR Text Key: 4500414
• Report Number: 9616099-2014-00348
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2014

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: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: EX700CE
• Device Lot Number: 16009010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 05/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1