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

Catalog Number SR*FF2419

Device Problem Fracture (1260)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided, age & date of birth: requested, not provided, patient sex: requested, not provided, weight: requested, not provided, ethnicity: requested, not provided, race: requested, not provided, expiration date: oct 2025, udi: not required for product code, implanted date: device was not implanted, explanted date: device was not explanted, device manufacture date: 11/02/20 ~ 11/05/20.The actual sample was returned for investigation.Upon closely checking the returned sample, the catheter was confirmed to be punctured by the inner needle, at the position 4mm away from the catheter tip.Based on the initial information received, we considered the issue to be not reportable.However, based on the results of the sample evaluation conducted on september 2nd, we noted the reportable issue and modified our decision to reportable.Retention sample check: the retention samples (5pcs) of the reported were prepared and visually checked under unopened package condition.As a result, no defective product that inner needle protruded from catheter, was observed.Manufacture inspection record check: the concerned product is continuously produced by fully automated machine, wherein the inner needle and the catheter assembled in one motion.Furthermore, the tip of every assembly is being checked by special digital camera after inner needle and catheter are assembled.In case of any defects, such as tip-deformation, everted catheter or catheter tip occlusion created during being assembled, those defects shall be detected by the camera, and the system will automatically segregate them from the line and reject.Manufacture inspection records of the reported lot were reviewed.As a result, no defective properties in the inspection machine and the automatic reject system were confirmed to be recorded.The results of the quality inspection, which is periodically conducted, recorded no defective product, such as tip deformation.Furthermore, no similar incidents were reported from other facilities.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.Ifu states: "do not attempt to re-insert a partially or completely withdrawn needle." terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported catheter damage on the terumo surflash i.V.Catheter.The catheter split on insertion.Additionally, through the succeeding communication made by our subsidiary company with the user, it was confirmed there was no report of catheter breakage, no medical intervention and no injury to the patient.No health hazard was reported.

• 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
• MDR Report Key: 12512162
• MDR Text Key: 272698279
• Report Number: 9681835-2021-00007
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K991406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SR*FF2419
• Device Lot Number: 201103A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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