MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH I.V. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

The user facility reported that the catheter involved had damage.During use of the catheter, the needle pierced the catheter as it was repositioned to the correct axis.The event occurred intra-operative.No harm was reported.There was no medical intervention following the accident.The procedure outcome was unknown.The final patient impact was unknown.

Manufacturer Narrative

A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3: patient sex: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d4: expiration date: sep 2026 h4: device manufacture date: 10/14/21-10/16/21 d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted h6: investigation findings - 3211 is based upon the evaluation of the photo provided; 213 is based upon the retention samples.H6 - investigation conclusion - 19 is based upon evaluation of the photo provided; 67 is based upon evaluation of the retention samples.The sample was not returned.Instead, the sample photo was provided.Upon closely checking the photo, the catheter was confirmed to be punctured by the inner needle at the catheter tip part.When we closely checked five (5) pieces of retention samples of the reported lot under unopened package condition, no defective products, which catheter was punctured by the needle, were observed.The concerned product is continuously produced by fully automated machine, wherein an inner needle and a catheter are assembled in one motion.Furthermore, the tip of assembly is being checked 100% by special digital camera after inner needle and catheter are assembled.In case of any defects, such as tip-deformation, catheter burr, or catheter tip occlusion occurred when assembled, those defects will be detected, and the system will automatically segregate them from the line and reject.The manufacture inspection records of the reported lot were reviewed.As a result, no defective properties in the inspection machine and automatic reject system were recorded.The results of the quality inspection, which is periodically conducted per lot, recorded no defective product, such as deformation in catheter tip.Furthermore, no similar incidents were reported from other facilities.The investigation, including manufacture inspection records checking, was thoroughly performed, especially to investigate if there was an assembly error of inner needle and catheter during production.However, no defective properties were observed, thus we were unable to identify the root cause of reported issue.Terumo medical products (tmc) (importer) registration no.2243441 is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.9681835.

• Brand Name: SURFLASH I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 18737377
• MDR Text Key: 336784991
• Report Number: 9681835-2024-00001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SR*FF2419
• Device Lot Number: 211013A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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