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 Number0001721729-2018-00010
MDR Report Key8011617
Date Received2018-10-28
Date of Report2018-10-26
Date of Event2018-09-25
Date Facility Aware2018-09-26
Report Date2018-09-28
Date Reported to Mfgr2018-09-28
Date Added to Maude2018-10-28
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHENRY SCHEIN PREMIUM NEEDLES 30GA SHORT
Generic NameHSP DENTAL NEEDLE
Product CodeDZM
Date Received2018-10-28
Returned To Mfg2018-10-15
Catalog Number02N2301
Lot NumberF07144AA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSOFIC SAS
Manufacturer Address3, RUE JEAN-JACQUES ROUSSEAU AUSSILLON MAZAMET CEDEX, 81207 FR 81207


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-28

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