HENRY SCHEIN STANDARD NEEDLES 30GA SHORT 02N1301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-12 for HENRY SCHEIN STANDARD NEEDLES 30GA SHORT 02N1301 manufactured by Sofic Sas.

Event Text Entries

[138548158] Spontaneous report, from the us. Local reference # (b)(4). Quality complaint file was opened; local complaint reference # (b)(4). Quality complaint: (b)(4). Dealer complaint reference #: (b)(4). Linked with local reference # (b)(4) (same reporting dentist, same affected patient(s), same suspect device, different reporting dental office). Initial information was received by dealer on 12-feb-2019 from reporting dental office and forwarded to septodont on 12-feb-2019. On (b)(6) 2019, suspect device henry schein standard needles 30ga short (batch # and expiration date: not specified) reportedly broke off at the hub while in a female pediatric patient's mouth. The needle involved reportedly was caught in time to be removed and the patient was not injured. Additional information is expected. Causality assessment on 19-feb-2019 on initial information received on 12-feb-2019: seriousness: serious (required intervention to prevent permanent impairment/damage (devices)). Expectedness: device breakage: unexpected us/(b)(4). Causality: latency - compatible, recognized association - no, analysis - this case reported a break at the hub of the suspected device henry schein standard needles 30ga short, requiring dentist intervention to remove the broken part. This case occured in a female paediatric patient. The possible causes of broken needle may result from: involuntary sudden movement of the patient, especially because it is a paediatric patient; involuntary movement or mishandling of the dentist during injection; the use of a needle size inappropriate to the type of procedure; unexpected contact with hard tissues (e. G. Bone); excessive bending of the needle before use or during use by the dentist; excessive pressure leading to a break of the needle; quality defect of the needles; the method used for the anaesthesia and the dental procedure are not specified. Since this case is poorly documented, no sufficient information is provided to explain the broke of the needle at the hub in the patient's mouth. Investigation tests are pending. Therefore, due to the lack of data, this case is considered as not assessable. Dechallenge - na. Rechallenge - na. Concluded causality who: not assessable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3002987375-2019-00002
• MDR Report Key: 8412715
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-03-12
• Date of Report: 2019-05-02
• Date of Event: 2019-01-02
• Date Mfgr Received: 2019-04-04
• Date Added to Maude: 2019-03-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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
• Manufacturer Street: 3, RUE JEAN-JACQUES ROUSSEAU
• Manufacturer City: AUSSILLON, MAZAMET CEDEX 81207
• Manufacturer Country: FR
• Manufacturer Postal: 81207
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HENRY SCHEIN STANDARD NEEDLES 30GA SHORT
• Generic Name: HENRY SCHEIN DENTAL NEEDLE
• Product Code: DZM
• Date Received: 2019-03-12
• Catalog Number: 02N1301
• Lot Number: NOT PROVIDED
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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	2019-03-12