MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE MCKESSON TUBERCULIN SYRINGE WITH NEEDLE SAFETYGLIDE¿; ANTISTICK SYRINGE

Catalog Number	305945
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (b)(4) tuberculin syringe with needle safetyglide¿ 1 ml 27 gauge 1/2 inch had a shield that was difficult to remove and had a needle that was difficult to separate from the syringe.The following information was provided by the initial reporter: "it is complicated to remove needle cover and not possible to figure out how to get needle ready to work.I had few colleagues around in attempts to remove safety component from needle and we could not.".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for evalution ?: yes d.9.Returned to manufacturer on: 21-apr-2022 h.6.Investigation: a representative sample and photo were received for evaluation.A quality engineer was able to review the picture and inspect the returned sample of (1) 1ml, 13mm, 27g bd safetyglide syringe in an open blister pack from lot # 1257282 with the reported issue that it was complicated to remove the needle cover and was not possible to figure out how to get the needle ready to work.The returned syringe was examined and observed to be fully activated.The returned photo indicated that the sample was used properly.Based on the sample and photo received, the investigation concluded that embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.A review of the device history record was completed for batch# 1257282.All inspections and challenges were performed per the applicable operations qc specifications.
Event or Problem Description
It was reported that mckesson tuberculin syringe with needle safetyglide¿ 1 ml 27 gauge 1/2 inch had a shield that was difficult to remove and had a needle that was difficult to separate from the syringe.The following information was provided by the initial reporter: "it is complicated to remove needle cover and not possible to figure out how to get needle ready to work.I had few colleagues around in attempts to remove safety component from needle and we could not.".

• Brand Name: MCKESSON TUBERCULIN SYRINGE WITH NEEDLE SAFETYGLIDE¿
• Common Device Name: ANTISTICK SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14242636
• Report Number: 1920898-2022-00296
• Device Sequence Number: 5015492
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: 00382903059454
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: Other
• Device Catalogue Number: 305945
• Device Lot Number: 1257282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown