MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO., LTD. DISPOSABLE INSULIN SYRINGE

Model Number	U-100 1ML 31G×5/16" 8MM
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of defects for batch 76241 insulin syringes: 1.Tubing rigidity & toughness tested per production batch.Batch records show all qualified, no anomalies.2.Ten retained samples of batch 76241 tested per iso9626.Rigidity deflection: 0.079-0.085 mm (max limit <0.180 mm).Toughness meets specs.(appendix 1 needle rigidity test data; appendix 2 medical needle tube (cannula) toughness test data) 3.Acceptable risk threshold: <10^-6.Total distributed units: (b)(4).Only 1 tubing break reported.Calculated risk: <10^-9, far below threshold.4.Tubing breakage caused by external force during use: 4.1 excessive insertion angle/depth creates lateral bending force.4.2 puncturing hard surfaces (vial glass) generates abnormal torsion/lateral force.4.3 repeated puncturing/position adjustment bends tubing at the same spot.5.Customer report states tubing bent during vial puncture.Bending falls into elastic (reusable) or permanent mechanical deformation.Conclusion: data confirms this rare low-probability incident stems from improper user operation.No immediate corrective actions per risk-benefit assessment.We will continuously monitor field complaints and respond based on future trends.
Event or Problem Description
I was on zepbound single vials.They send easy- touch needles.31 gauge 5/16 lot number 76241, item 63116102, manufactured 11-05-2025, exp-11-04-2030.These needles bend when you insert then into the vial.Sometimes they bend left or right and sometimes they just crumple on themselves.During my most recent injection the needle broke off under my skin in the lower abdomen.I went to the emergency room.Both an x ray and ultrasound was done and they confirmed a retained fragment of the needle and placed me on antibiotics.I have an appointment with general surgeon (b)(6) in approximately one week, i had reported this earlier to someone at (b)(6) but cannot tell you who.This time i spoke with (b)(6) at (b)(6).

• Brand Name: DISPOSABLE INSULIN SYRINGE
• Common Device Name: DISPOSABLE INSULIN SYRINGE
• Manufacturer (Section D): BERPU MEDICAL TECHNOLOGY CO., LTD.; no.14 xingji road, yongxing; longwan district; wenzhou, zhejiang province 32500 0; CH 325000
• Manufacturer (Section G): BERPU MEDICAL TECHNOLOGY CO., LTD.; no.14 xingji road; longwan district; wenzhou, zhejiang province 32500 0; CH 325000
• Manufacturer Contact: buxin yu ; no.14 xingji road; longwan district; wenzhou, zhejiang province 32500-0 ; CH 325000
• MDR Report Key: 25522676
• Report Number: 3004496829-2026-00001
• Device Sequence Number: 10557973
• Product Code: FMF
• UDI-Device Identifier: MHC1631161022
• UDI-Public: +MHC1631161022/$$776241/16D20251105/14D20301104I
• Combination Product (Y/N): N
• PMA/510(K) Number: K162180
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: U-100 1ML 31G×5/16" 8MM
• Device Lot Number: 76241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White