MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURSHIELD SAFETY I.V. CATHETER; INTRAVASCULAR CATHETER

Catalog Number SR-SFA1832

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product lot number is unknown and the following are potential lots/manufacturer date/expiration dates: (1) 160601h/05-31-16 thru 06-01-16/may 31, 2021 (2) 161101h/11-01-2016 thru 11-02-16/october 31, 2021 (3) 161208h/12-08-16 thru 12-10-2016/november 30, 2021.The actual sample photo was obtained for investigation.The image revealed that the catheter was damaged and inflected.The damaged portion appeared to be a smooth cut.Details were unable to be identified from the photo base observation.Retention samples, three pieces per lot, were observed.No anomalies were found.The manufacture inspection record was traced back to the potential lot.No defective properties were detected.There has been no similar events reported for the concerned lot by other medical institutions.The exact cause of the reported event cannot be definitively determined based on the available information.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: do not attempt to re-insert a partially or a completely withdrawn needle.(b)(4).

Event Description

The user facility reported catheter damage with the involved device during a procedure.Follow up communication with the user facility reported the following information: during a medical checkup on (b)(6), the patient was administered on the upper right arm and it was secured with a 18g.The patient wanted to stay overnight and on (b)(6), the doctor decided to remove one of unused transfusion lines.The catheter connected to the line was then damaged and remained inside the vessel.Since the fragment that was inside the skin was not visible, however gave a sense when touched, an echography was performed upon consultation with a doctor.An incision was later performed by a surgeon to remove the fragment.The fragment of the catheter was successfully removed from the patient.There were no other devices or equipment being used with the reported product.

• Brand Name: SURSHIELD SAFETY I.V. CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; reg. no. 9681835; 1727-1, tsuiji-arai, showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7066421
• MDR Text Key: 93176733
• Report Number: 9681835-2017-00036
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SR-SFA1832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention