MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SHOULDER PACK

Catalog Number	DYNJ55745B
Medical Device Problem Codes	Scratched Material (3020); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported issues with the new shoulder packs in that the 18g 3 ½" spinal needle was not allowing the stylet to be removed, and they could get it about half way out but could not get it removed.A sample was received for investigation; one unused needle was reviewed, finished good production records were reviewed, and the bill of materials was reviewed.Based on the investigation and sample evaluation, the reported issue was confirmed, and it was determined that the component is not altered during the kitting process; the root cause is a vendor product issue.The vendor reviewed the provided sample and found a large scratch on the inner needle, determined the root cause to be narrow clearance between the inner and outer needles, and the division will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
Event or Problem Description
It was reported that "the 18g 3 ½" spinal needle is not allowing the stylet to be removed.They can get it about half way out but can¿t get it removed.".

• Brand Name: MEDLINE
• Common Device Name: SHOULDER PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871122
• Report Number: 1417592-2026-49151
• Device Sequence Number: 9379781
• Product Code: LRO
• UDI-Device Identifier: 10198459314506
• UDI-Public: 10198459314506
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Catalogue Number: DYNJ55745B
• Device Lot Number: 25DBD601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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