MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PERMANENT PACING PACK-LF

Catalog Number	DYNJ22036F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that while a physician was injecting lidocaine into a patient, the needle broke off.The needle was retrieved.It was further mentioned that this event did not cause harm to the patient.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported required medical intervention to retrieve the broken needle, this medwatch is being filed.The sample is not available for returned and evaluation.A definitive root cause therefore could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported component piece 25 gauge needle broke off while injecting lidocaine.

• Common Device Name: PERMANENT PACING PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9849916
• Report Number: 1423395-2020-00007
• Device Sequence Number: 2764198
• Product Code: OEZ
• UDI-Device Identifier: 10889942528899
• UDI-Public: 10889942528899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: Health Professional
• Device Catalogue Number: DYNJ22036F
• Device Lot Number: 19HBJ744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention