MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4055-24
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Rupture (2208)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that 10-20 days following implant of a smiths medical port-a-cath®ii implantable access systems the skin is reported to rupture causing the chamber to come out.Subsequently, the patient was brought to surgery for intervention which was reported to delay chemotherapy treatment.No further adverse effects were reported.
Additional Manufacturer Narrative
One picture was received by shm, and its can be observed a male luer broken from the inlet connection.No testing could be performed because no samples were provided to perform a thorough investigation.Due to the fact there was no lots for p/n 21-7359-24 programed to be manufactured in the near future, a review of the manufacturing process for p/n 21-7333-24 l/n 3776361 was conducted by quality engineer in order to verify that there are no situations or practices that could create the event as described in "complaint description" section.No root cause has to be determined since the reported failure mode was not confirmed due to the fact that no samples were received to perform a thorough investigation.No actions are required since the complaint was not confirmed.However, manufacturing personnel was notified by the area supervisor as awareness of the failure mode reported by the customer.The problem source of the reported problem is unknown.

• Brand Name: PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7350658
• Report Number: 3012307300-2018-00631
• Device Sequence Number: 37478
• Product Code: LJT
• UDI-Device Identifier: 10610586023552
• UDI-Public: 10610586023552
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K962695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: 21-4055-24
• Device Lot Number: 3349908
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention