MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 20GA 1IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	INCORRECT ENTRY
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:305175.Batch#:2056681.It was reported by customer that the clinical anesthesia team recently found blocked hypo bd needles.Verbatim: "nous avons reçu une réclamation pour les articles bd 305175 et 305106, l¿équipe clinique d¿anesthésie a récemment trouvé des aiguilles hypo bd bloquées." "pour l'article # 305175, on n'est pas certain car l'emballage a été jeté, mais il se peut qui soit un de ces lots: 2056681, 21117190 ou 20209321" "we have received a complaint for bd 305175 and 305106 items, the clinical anesthesia team recently found blocked hypo bd needles." "for item # 305175, we are not sure because the packaging has been discarded, but it may be one of these lots: 2056681, 21117190 or 20209321" additional information: 1.Veuillez nous indiquer la date où l¿incident s¿est produit.Veuillez confirmer si les numéros de lot sont 21117190 et 20209321, et s¿ils sont touchés ? either one was a possibility most reported incident: (b)(6) 2024.The packaging was discarded, but upon verification of the bd needles in the or, the lot number could be narrowed down to 2 -lot: 2020931 or 2056681 2.Êtes-vous en mesure de nous fournir un échantillon représentatif du produit pour fins d¿enquête ? yes 3.Veuillez également nous fournir une adresse pour la collecte de l¿échantillon, le nom et le numéro de poste de la personne-ressource, le nom et l¿étage de son unité de service ainsi que tout autre détail pertinent ((b)(6).If someone will come to pick-up at the hospital: the best place is by the security desk in (b)(6).Please use the phone by security to call (b)(6), attention / (b)(6), rrt.Otherwise, a return label can be sent to the (b)(6) attn: (b)(6) 4.L¿incident a-t-il mis en cause un patient ou un utilisateur, directement ou indirectement ? no.5.Combien de fois le problème est-il survenu ? reported 5-6 times in the last 3 months.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information received.Material #:305175.Batch#:2056681.It was reported by customer that the clinical anesthesia team recently found blocked hypo bd needles.Verbatim: "nous avons reçu une réclamation pour les articles bd 305175 et 305106, l¿équipe clinique d¿anesthésie a récemment trouvé des aiguilles hypo bd bloquées." "pour l'article # 305175, on n'est pas certain car l'emballage a été jeté, mais il se peut qui soit un de ces lots: 2056681, 21117190 ou 20209321"."we have received a complaint for bd 305175 and 305106 items, the clinical anesthesia team recently found blocked hypo bd needles." "for item # 305175, we are not sure because the packaging has been discarded, but it may be one of these lots: 2056681, 21117190 or 20209321".Additional information: 1.Veuillez nous indiquer la date où l¿incident s¿est produit.Veuillez confirmer si les numéros de lot sont 21117190 et 20209321, et s¿ils sont touchés ? either one was a possibility.Most reported incident: (b)(6) 2024.The packaging was discarded, but upon verification of the bd needles in the or, the lot number could be narrowed down to 2 -lot: 2020931 or 2056681.2.Êtes-vous en mesure de nous fournir un échantillon représentatif du produit pour fins d¿enquête ? yes.3.Veuillez également nous fournir une adresse pour la collecte de l¿échantillon, le nom et le numéro de poste de la personne-ressource, le nom et l¿étage de son unité de service ainsi que tout autre détail pertinent (par ex., collecte à la réception, au quai de livraison, etc.).If someone will come to pick-up at the hospital: the best place is by the security desk in (b)(6) entrance is located @ (b)(6).Please use the phone by security to call @ (b)(6), attention / (b)(6), rrt.Otherwise, a return label can be sent to the jgh attn: (b)(6) 4.L¿incident a-t-il mis en cause un patient ou un utilisateur, directement ou indirectement ? no.5.Combien de fois le problème est-il survenu ? reported 5-6 times in the last 3 months.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there were blocked needles.To aid in the investigation, one sample with two packaging blisters, one from lot 2020931 and one from lot 2056681, were received for evaluation by our quality team.A visual inspection was performed, and inside the needle hub there is a hard material blocking the needle.The sample was connected to a syringe with saline solution.It was not possible to expel the solution; the needle is clogged.This defect could occur if the epoxy applied to fix the needle to the hub flowed to the bottom of the needle.A device history record review was completed for material number 305175, possible lots 2020931 and 2056681.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: NEEDLE 20GA 1IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18739004
• Report Number: 1911916-2024-00109
• Device Sequence Number: 6380626
• Product Code: FMI
• UDI-Device Identifier: 30382903051756
• UDI-Public: (01)30382903051756
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2024

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: INCORRECT ENTRY
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/10/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown