MAUDE Adverse Event Report: YANGZHOU MEDLINE INDUSTRY CO.LTD. YANGZHOU MEDLINE INDUSTRY CO.LTD.; SAFETY NEEDLE

Catalog Number N-2515

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

The customer reported after vaccine is drawn up during the injection the medicine leaked from the needle/syringe.Our main issue is the majority of our patients fall into the 1" needles.In every covid-19 kits we have received there are not enough 1" needles included for the majority of our size patients.No information was received regarding any serious injury as a result of this product malfunction.

Manufacturer Narrative

According to the production records, the batch number is (b)(4), specification is 25gx1-1/2'', and product code is n-2515.There are no similar abnormalities in the production and inspection records during the production process; according to the customer's complaint, the raw material inspection shows that the performance of granular and needle meets the requirements; after the re-inspection of reserved samples (same batch) and the confirmation of products in process, the relevant dimensions of the connecting parts meet the requirements.Matching, separation force and tightness performance can meet the requirements of iso80369 standard; according to the above investigation and testing, our product can fully meet the tightness requirements according to the manual requirement, and there will be no leakage.Therefore, the use of our safety needle must be operated in accordance with the manual requirements, so as to avoid the phenomenon described in the customer complaint.

• Brand Name: YANGZHOU MEDLINE INDUSTRY CO.LTD.
• Type of Device: SAFETY NEEDLE
• Manufacturer (Section D): YANGZHOU MEDLINE INDUSTRY CO.LTD.; no 108,jinshan road; economic development zone; yangzhou, jiangsu 22500 9; CH 225009
• Manufacturer (Section G): WEIWEI CUI; no.108, jinshan road; economic development zone; yangzhou, jiangsu 22500 9; CH 225009
• Manufacturer Contact: weiwei cui ; no.108, jinshan road; economic development zone; yangzhou, jiangsu 22500-9 ; CH 225009
• MDR Report Key: 12765537
• MDR Text Key: 281281727
• Report Number: 3010732234-2021-00002
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 06970114923950
• UDI-Public: (01)06970114923950(17)251112(10)SN201114
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2021

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: N-2515
• Device Lot Number: SN201114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2020
• 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