MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. RETRACTABLE TECHNOLOGIES - SYR TS 1CC VANSHFT 27GX1/2; SYRINGE - NEEDLE DISPOSABLE, LAWSON#333826

Catalog Number CIN: 4098638

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/02/2016

Event Type  malfunction  

Event Description

As the rn was using the syringe to inject lovenox into the patient's abdomen, the patient for some reason turned towards the patient's left side.The rn attempted to maintain proper alignment of the syringe to the patient's abdomen but the needle broke off and lodged in the patient's abdomen; confirmed by x-ray.Treatment plan at present: undetermined.

• Brand Name: RETRACTABLE TECHNOLOGIES - SYR TS 1CC VANSHFT 27GX1/2
• Type of Device: SYRINGE - NEEDLE DISPOSABLE, LAWSON#333826
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 5636633
• MDR Text Key: 44703703
• Report Number: MW5062103
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CIN: 4098638
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 50