MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU LUER ADAPTER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

Date of event: requested, not provided, lot number: requested, unknown, expiration date: unknown due to unknown lot number, udi - not required for product code, implanted date: device was not implanted, explanted date: device was not explanted, initial reporter name : mr./ms.(b)(6), occupation: office clerk.(b)(4).No samples were returned for our investigation.When we closely checked the retention samples of the most recent lot, no deformation or defective molding condition were observed in each part, including push buttons and caps of blood collection tube holder.Moreover, no defective shapes were observed in the hub of luer adapter s, which is the connection part with blood collection tube holder.Drawing performance was checked utilizing water and our in-house blood collection tube, wherein water was able to be drawn and no breakage or disconnection between luer adapter s and blood collection tube holder was observed.The manufacture inspection records of the reported product type for two and half past years were traced back and reviewed.As a result, no defective condition, which may have caused product breakage, was noted.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.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 a needle stick.The connection between the needle attachment (white portion) and the transparent part (holder body) came off.Since this issue occurred during manipulation, the user received a needle stick injury.The event occurred intra-operative.The patient was not injured, and no medical or surgical intervention was required.

• Brand Name: LUER ADAPTER
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvid; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14742432
• MDR Text Key: 302578038
• Report Number: 9681835-2022-00011
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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: MN-HD2000S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2022
• 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