MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested but not provided, age and date of birth - requested but not provided, weight - requested but not provided, ethnicity - requested but not provided, race - requested but not provided, udi - unknown due to the lot number being unknown, lot number - unknown, expiration date - unknown due to the lot number being unknown, implanted date: device was not implanted, device manufacture date - unknown due to lot number being unknown.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.All cannula supplied as raw material complies with iso 9626, for stiffness and breakage.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.(b)(4).

Event Description

The user facility reported that the needle came off of the hub and is still in patient.Additional information was received on 12/6/2017.The patient was receiving a pudendal nerve block.The 30g, ½" needle was inserted into the right thigh in the ischial tuberosity area and injection was performed without incident.The doctor then went to repeat the injection on the left side.After insertion of the needle through the skin there was resistance upon injection.She pulled the syringe back to reposition and attempt injection and there was still resistance.She then pulled the whole syringe out of the patient and the needle remained in the patient.The needle was not removed from the patient.It is in the subcutaneous fat.It was reported that the needle was not bent or angled in any way by the physician.It was a straight stick.The tissue was smooth and soft.The patient is in good condition without any pain or issues.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, reg. no. 3003902955 ; RP
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7112387
• MDR Text Key: 94655785
• Report Number: 3003902955-2017-00052
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 102-N3005S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/13/2017
• 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): Other