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

Catalog Number	21-4471-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00279, 3012307300-2018-00280, 3012307300-2018-00282 3012307300-2018-00283.Lot number provided by customer is not a valid lot number.
Event or Problem Description
It was reported that the explanting doctor noticed holes in the catheter of a deltec® port-a-cath®ii power p.A.C.Implantable access system.Issues with the catheter had to be explanted when one patient complained of pain.There was no patient injury associated with this occurrence.
Additional Manufacturer Narrative
One smiths medical deltec® port-a-cath®ii was returned for analysis in a used condition.Under visual exam a hole to the catheter was noted, the port was damaged and blood was seen.The complaint was confirmed.Relevant documents were reviewed and deemed adequate.The manufacturing process was reviewed which noted that all procedures are being carried out appropriate.The assembly process was performed according to the procedures listed above.The training documents were reviewed and confirmed that the personnel had trainings up to date.The following process were reviewed: line clearance; correct identification of all components; catheter stress relieve; cut to length.It is use fixture (b)(4) and it is measured with a ruler (id (b)(4), due date: 09/19); cath tip forming; cat tip polishing; cath patency test, methanol dipping & drying; cath printing; cath final cleaning; a 100% visual inspection to the units is performed to assure that the components are not bent, kinked, or otherwise damaged.All were adequate with no discrepancies found.A sample of (b)(4) catheters were taken from the manufacturing process finding the following: the components are not bent, kinked, or otherwise damaged; production personnel tests 100% the units for occlusion or leaks; quality personnel take a sample size.Based on the evidence, the most probable root cause was from damage that occurred after the product left the manufacturing facility.

• Brand Name: DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• MDR Report Key: 7278787
• Report Number: 3012307300-2018-00281
• Device Sequence Number: 16579884
• Product Code: LJT
• UDI-Device Identifier: 10610586032745
• UDI-Public: 10610586032745
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: Health Professional
• Device Catalogue Number: 21-4471-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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: Required Intervention