MAUDE Adverse Event Report: COVIDIEN HYPO NEEDLE 27X1 1/2 A BEVEL; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1188827112
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the needles have a leak.Additional information received from the customer stated that the locking part of the needle does not lock on to the syringe and causes leaking.No patient harm reported.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.There were 53 (unopened, unused) samples submitted with this complaint.Thirty samples were visually inspected, specifically in the luer of the hub of the needle.No damage/deformity were found in all the samples inspected.The samples were physically tested per product specification for leakage.All samples passed the testing.The reported condition could not be replicated or confirmed.An exact root cause for the reported condition was not identified but may occur during use.The instructions for use require the user to seat the needle to any standard luer lock syringe with a firm push and clockwise twist.If there is any variation of the instructions, there is the possibility for the needle not to function properly.The exact method of attachment cannot be determined based on available information.Based on this analysis, this root cause cannot be confirmed or discarded from consideration, so it remains as a potential root cause.At this time, there is no trending or information that would trigger the need to initiate a corrective/preventative action (capa).

• Brand Name: HYPO NEEDLE 27X1 1/2 A BEVEL
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8976684
• Report Number: 1017768-2019-00676
• Device Sequence Number: 18909744
• Product Code: FMI
• UDI-Device Identifier: 10884521007444
• UDI-Public: 10884521007444
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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
• Operator of Device: No Information
• Device Model Number: 1188827112
• Device Catalogue Number: 1188827112
• Device Lot Number: 908000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 11/26/2019
• Patient Sequence Number: 1