MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SAFETY BLOOD COLLECTION NEEDLE 21GX1

Catalog Number	DYNDSBCN21GZ
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Retraction Problem (1536)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needle cover is not coming back down over the needles and blood is continuing to flow out of the needle after removing the tube.".
Additional Manufacturer Narrative
The customer reported blood exposure events in which ¿the needle cover is not coming back down over the needles and blood is continuing to flow out of the needle after removing the tube,¿ ¿today we got blood all over the tubes, the patient and work area,¿ and later stated ¿tubes are flying off the hubs.Blood is dripping from inside the vacutainer holder where the sheath is not retracting back down.Needles don¿t screw onto holders securely¿; the customer also stated the ¿patient was traumatized by their own blood dripping onto them after collection¿ and answered ¿no¿ to serious injury, medical intervention, follow-up care, and post-exposure tasks.At this time, a sample(s) was not received for investigation; the investigation included review of recent complaint trends/scar activity for the past 3 months, and review of the last three trend reports found no trends for the specified material number and corresponding defect type.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo, and ¿sample required to determine cause.¿ based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications; there was no reported death or serious injury, no further action was taken because objectionable trends were not seen, and if a sample, photo and/or additional information becomes available this complaint will be reopened to be further investigated.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.

• Brand Name: MEDLINE
• Common Device Name: DBD-SAFETY BLOOD COLLECTION NEEDLE 21GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50819124
• Report Number: 1417592-2026-44720
• Device Sequence Number: 16005046
• Product Code: JKA
• UDI-Device Identifier: 20193489007876
• UDI-Public: 20193489007876
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K220900
• 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): 09/17/2026

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: DYNDSBCN21GZ
• Device Lot Number: (10)211201
• Was Device Available for Evaluation?: Yes
• 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: 08/22/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown