MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH ULTRA LITE; INTRODUCER, CATHETER

Model Number VI10

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Our device evaluation is still in progress, follow up report will be submitted when device analysis is completed.

Event Description

It was reported that during the distributor's receiving inspection several samples of lot dp-11759 was found to have a premature sterile breach.There was no patient involvement reported.No additional information reported.

Manufacturer Narrative

Customer/(distributor) returned one unit from lot dp-11759 with an opened seal which they found in their packaging process on 9th february.This unit was not burst tested.Customer (distributor) also returned additional units from their inventory for evaluation and investigation.On 7th february customer (distributor) returned ten (10) units without outer box from the complaint lot dp-11759.Customer (distributor) also returned fifteen (15) units from lot dp-12351.On february 16th, customer (distributor) returned additional 30 units from lot dp-11759 from their inventory.Visual inspection : · all fifteen (15) units from lot dp-12351 found to have intact seal.· nine (9) units from lot dp-11759 observed to have some stress on seal caused by the dilator hub and one (1) unit was found to have partial seal.· ten (10) pouches from the lot dp-11759 and five (5) pouches out fifteen (15) from the lot dp-12351 were measured using a ruler and were found to be within specification (4.25"×10.9").Sheath and dilator packaged in the pouch measured to be 8.5" which is correct to its specification.These fifteen (15) units were burst tested as per procedure and met the 0.5psi burst criteria.· 10 units were labeled as open seal and were confirmed upon visual inspection to be opened at the seal.These units were not burst tested.· 10 units were labeled for seal creep or delamination defect.Upon visual inspection of these units, these defects were confirmed.5 samples each with seal creep/delamination defects were tested for burst test and peel test (total 10 samples).It was found that 4 out 5 samples failed to meet the 0.75lb/in peel strength specification.One (1) out of four (4) samples failed to meet the 0.5psi burst test results.· 10 units were labeled as no visual defects.Upon visual inspection, all the seals were found to be intact and no defective seals were found.Five (5) samples were tested for burst test and five (5) for peel test (total 10 samples).It was found that all samples meet the 0.75lb/in peel strength specification and 0.5psi burst test specification.Upon investigation of the returned units, visual inspection showed that the seal was stressed at the dilator hub side.It was observed that the dilator hub side was pushed into the seal that further created a gap and created seal creep.When the seal creep was evaluated, it was confirmed the sealer or the sealing process was not creating seal defects.Seal creep was a combination of the product being pushed into the seal and gap created by the dilator at the seal.Personnel involved in sealing pouches were immediately interviewed and notified about the reported complaint.Also, the supplier test data for the pouch lots found to be within specifications and met receiving inspection requirements at oscor.The seal creep and the weakening (gap) in the seal was likely caused by the dilator hub being pushed into the seal.It is unknown if this was caused during handling or packaging process at the distributor site.This defect was first identified during packaging process at customer (distributor) site and not during customer's (distributor) incoming inspection.To further investigate the issue capa was initiated.Hhe was completed which resulted in field action/recall.Dhr review of the complaint lot showed that all the units passed in house burst test and the correct parameters were used for sealing the pouches during manufacturing.Sealer preventive maintenance records were reviewed and no issues were found.Per adelante s/adelante s lite large/sigma/sigma at packaging: verify that the correct dilator and sheath are being used.Place the sheath into one end of the packaging tubing.From the other end of the packaging tubing, place the dilator into the sheath.Note: the dilator should now be inverted into the sheath/tubing but should not penetrate the sheath seal.Be careful not to damage the tips of the dilator and sheath per introducer pouch packaging inspection(qa): verify that the pouch has a proper seal.Sealed area must be continuous.No voids, breaks and/or bubbles along the seal.The seal should be at least 1 cm from the top of the pouch.Examine the seal for uniformity.Check for holes or any other damages that could violate sterility.Based on investigation capa is initiated to further investigate the issue.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: SAFESHEATH ULTRA LITE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 11398033
• MDR Text Key: 234224333
• Report Number: 1035166-2021-00020
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 25051684026298
• UDI-Public: 25051684026298
• Combination Product (y/n): N
• PMA/PMN Number: K073100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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 Model Number: VI10
• Device Catalogue Number: VI10
• Device Lot Number: DP-11759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1035166-03/04/2021-01-R
• Patient Sequence Number: 1