MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328519
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.".
Event or Problem Description
It was reported that a syringe 1.0ml 31g 6mm s/c u-100 relion was difficult to aspirate during use.The following was reported by the initial reporter: "it was reported that needle will not draw.Verbatim: from phone call on (b)(6) 2021 14:36:06: called consumer to obtain lot #, he provided lot # 9182252.Consumer said he received the mail kit so i asked him to return the samples as soon as possible and he said he will.From phone call on (b)(6) 2021 17:26:06: called consumer to obtain lot #, consumer stated that he did not have the lot # but he will call back and leave a voicemail if we are closed.Voicemail: consumer left voicemail reporting that the needle will not draw.".
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
Event or Problem Description
It was reported that a syringe 1.0ml 31g 6mm s/c u-100 relion was difficult to aspirate during use.The following was reported by the initial reporter: "it was reported that needle will not draw.Verbatim: from phone call on 2021-04-12 14:36:06: called consumer to obtain lot #, he provided lot # 9182252.Consumer said he received the mail kit so i asked him to return the samples as soon as possible and he said he will.From phone call on 2021-04-07 17:26:06: called consumer to obtain lot #, consumer stated that he did not have the lot # but he will call back and leave a voicemail if we are closed.Voicemail: consumer left voicemail reporting that the needle will not draw.".

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11720801
• Report Number: 2243072-2021-01249
• Device Sequence Number: 11868988
• Product Code: FMI
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1