HENRY SCHEIN PREMIUM NEEDLES 30GA SHORT 02N2301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-28 for HENRY SCHEIN PREMIUM NEEDLES 30GA SHORT 02N2301 manufactured by Sofic Sas.

Event Text Entries

[125274936] Spontaneous report, from the us. (b)(4). Quality complaint file was opened; (b)(4). Linked with (b)(4) (same reporter, same suspect device, different identifiable patient). Initial information received on (b)(6) 2018; follow-up #1 information was received on (b)(6) 2018; follow-up #2 information was received on (b)(6) 2018. Initial, follow-up #1, and follow-up #2 information received are integrated in below case narrative. The suspect device henry schein premium 30ga short needles (batch #1: f04497aa, expiration date: 2020-10; batch #2: f07144aa, expiration date: 2023-02) was used for injection during a dental filling procedure on two adult patients (gender and age unspecified), on either (b)(6) 2018. The syringe type used was screw-on type. No issues were reported while screwing the suspect needle onto the syringe. On (b)(6) -2018, during the injection, the hub and the needle cannula disconnected, with the needle hub stay connected to the syringe while the whole needle cannula stayed behind in the patient. No needle was reported broken. The dentist was able to retrieve the needle from the patient's mouth. Needle samples were expected to be returned for investigation. Causality assessment on 09-oct-2018 on initial information and additional information received on (b)(6) 2018 and follow-up information received on (b)(6) 2018: a. Seriousness: serious (required intervention to prevent permanent impairment/damage (devices)) b. Expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/ca; needle issue: unlisted eu, unexpected us/ca. C. Causality: a) latency: suggestive. B) recognized association: no. C) analysis: in this case, the cannula of the needle has detached from the hub during a buccal injection for two patients with the same practitioner. Quality investigation is ongoing. At the time of this report, information was not sufficient to allow a causality assessment. Pending the results of quality control, the case report was considered as not assessable. D) dechallenge: na. E) rechallenge: na. Concluded causality who: not assessable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001721729-2018-00010
• MDR Report Key: 8011617
• Date Received: 2018-10-28
• Date of Report: 2018-10-26
• Date of Event: 2018-09-25
• Date Facility Aware: 2018-09-26
• Report Date: 2018-09-28
• Date Reported to Mfgr: 2018-09-28
• Date Added to Maude: 2018-10-28
• 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: 0

Device Details

• Brand Name: HENRY SCHEIN PREMIUM NEEDLES 30GA SHORT
• Generic Name: HSP DENTAL NEEDLE
• Product Code: DZM
• Date Received: 2018-10-28
• Returned To Mfg: 2018-10-15
• Catalog Number: 02N2301
• Lot Number: F07144AA
• 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	2018-10-28