MAUDE Adverse Event Report: COVIDIEN HYPO NEEDLE 30G X 3/4 A BEV RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881250032
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 the syringes lock up and do not plunge.
Additional Manufacturer Narrative
Based on additional information received from the initial reporter received on 13-aug-2019 section b5 was updated.Based on the updated event description, this event is no longer considered a reportable malfunction and no further reports will be forwarded.
Event or Problem Description
The customer reported that the needle is blocked/occluded.

• Brand Name: HYPO NEEDLE 30G X 3/4 A BEV RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8771918
• Report Number: 1017768-2019-00654
• Device Sequence Number: 11189539
• Product Code: FMI
• UDI-Device Identifier: 20884521025728
• UDI-Public: 20884521025728
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 8881250032
• Device Catalogue Number: 8881250032
• Device Lot Number: 903502
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1