MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS

Catalog Number S-1100-08LF

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Not Applicable (3189)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

There are small holes in the packaging.There was no patient involvement.

Manufacturer Narrative

(b)(4).Visual inspection was performed to 1 piece from product code s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) received as part of this complaint.Sample is received sealed with it label and insert, during visual inspection it was observed a highlight section by customer where a little marks can be observed.A bubble test was applied to header bag where a section was highlight; does not present any leak issue.No quality reports were found during incoming inspection.The final release technician was contacted in order to investigate if damage reports have been notified from the dc or sterilizer, no damage reports was reported to lot number.Complete process revision was performed it did not identify any process that could origin the marks reported.No corrective actions can be established since according to additional test no perforations were detected in header bag received.The device history review showed that there were no issues related to the reported failure mode neither on the product or its components during the manufacture of this material.The condition reported as "holes" is not observed on sample provided.The root cause of the issue reported is unknown.Teleflex will continue to monitor and trend related events.

Event Description

There are small holes in the packaging.There was no patient involvement.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 6835711
• MDR Text Key: 84688490
• Report Number: 3004365956-2017-00342
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74B1700902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1