PATTERSON 27G LONG NEEDLE 05N1272

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for PATTERSON 27G LONG NEEDLE 05N1272 manufactured by Sofic Sas.

Event Text Entries

[128925448] Spontaneous report from the us. Local reference # (b)(4). Quality complaint was opened. (b)(4). Initial information received on (b)(6) 2018 by dealer sales representative and follow-up #1 information on (b)(6) 2018 from the dealer by phone. Both initial and follow-up #1 information are integrated "in" below. Case narrative: on (b)(6) 2018, the dentist complained "of" that suspect device patterson 27 gauge long needle (batch # f06844aa, exp: 2022-10) was weak at the hub, and it broke off with slight bend. Date of incident was not reported and during this episode, the patient did not "experienced" adverse reaction and damage. At time of follow-up contact on (b)(6) 2018, dealer learned from the reporting dental office that the suspect device in fact "was" broke in the patient's mouth. The suspect device was inserted, then broke "twice". Patient details are not specified (age, gender, intention for dental treatment, etc. ). The dentist indicated that the "patient(s)'s" outcome is stable and unaffected by this incident. Additional follow-up with reporting dentist is currently underway. Causality assessment performed on 20-nov-2018 on initial information received on (b)(6) 2018 and additional information received on (b)(6) 2018: seriousness: serious (required intervention to prevent permanent impairment/damage (devices). Listedness/expectedness: needle issue: unlisted eu, unexpected us/ca; no adverse event: listed eu, expected us/ca. Causality: latency: compatible. Recognized association: no. Analysis: needle breakage occurred in the mouth of an unspecified patient while using the medical device. The possible causes of this event may be an excessive pressure or movement of the needle during injection, the use of a needle size inappropriate to the type of procedure, possible patient movements during injection due to his anxiety or needle defect. Based on the few information provided, no assessment can be performed and therefore the causal relationship between the device and the events was considered as not assessable. Concluded causality who: not assessable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001721729-2018-00013
• MDR Report Key: 8120759
• Date Received: 2018-11-30
• Date of Report: 2019-02-21
• Date of Event: 2018-11-01
• Date Facility Aware: 2018-11-09
• Report Date: 2018-11-30
• Date Reported to FDA: 2018-11-30
• Date Reported to Mfgr: 2018-11-16
• Date Added to Maude: 2018-11-30
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PATTERSON 27G LONG NEEDLE
• Generic Name: PATTERSON NEEDLE
• Product Code: DZM
• Date Received: 2018-11-30
• Returned To Mfg: 2018-11-22
• Catalog Number: 05N1272
• Lot Number: F06844AA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SOFIC SAS
• Manufacturer Address: 3, RUE JEAN-JACQUES ROUSSEAU AUSSILLON MAZAMET CEDEX, 81207 FR 81207

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-11-30