MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; SPINAL ANESTHESIA KIT

Model Number	560074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility: it was reported the needle broke in patient's back.The needle was retained in the patient's back requiring surgery to remove it.Foreign object removed from the l3 and l4 level, laminoforaminotomy.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4) and it's being submitted to provide the following information: batch number, manufacturing date and expiry date.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two unopened samples of another manufacturer's needles (wipak medical) and one used, unidentified broken partial needle with no packaging was returned for evaluation from the reporting facility.In addition, three photos were provided for evaluation by the reporting facility.After further clarification from the customer, it was confirmed that needles from the b braun kit were packaged in two 3m cardboard sleeves and sealed in a wipak medical blister package.Visual evaluation of one of three photos showed four needles out of the packaging with one being bent at the tip.It should be noted the needles did match what was packaged in the returned wipak medical product.The second photo showed a used, bent needle with no hub, and the third photo showed lidstock packaging from b braun item 560074.The sealed wipack blisters were opened and evaluated by the kits business unit supervisor, and one partial needle with a hub in one of two wipak blisters was part of the broken needle that was in the plastic, unidentified container.The used broken/sheared spinal needle was visually severely damaged and bent.However, this is not believed to be the result of any manufacturing process.The retain sample for the reported kit lot and an additional house retain samples of the spinal needle were evaluated and no samples showed any damage to the needle or hub.All visual specifications were met.The house retain sample contained all components according to the product drawing.Additionally, a review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.Although the needle was broken off, since it was not broken or damaged upon the opening of the kit and it had been used in a procedure, per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.User will be referred to the ifu which states, " do not apply excessive force during needle advancement.Do not utilize needle if it bends or tip becomes damaged.If resistance is feltduring advancement of the needle, carefully correct the orientation of the needle but never apply excessive force." we will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two unopened samples of another manufacturer's needles (wipak medical) and one used, unidentified broken partial needle with no packaging was returned for evaluation.No b braun product was returned.In addition, three photos were provided for evaluation.Visual evaluation of one of three photos showed four needles out of the packaging with one being bent at the tip.It should be noted the needles match what was packaged in the returned wipak medical product.The second photo showed a used, bent needle with no hub, and the third photo showed lidstock packaging from b braun item 560074.However, no photo confirmed the reported bent or broken needle to definitively be from item# 560074.Although there was a photo of lidstock from item 560074, the other provided photos and actual returned samples did not confirm any defect to b braun product.A thorough investigation could not be performed without the actual b braun samples to evaluate.The exact root cause was unable to be determined at this time.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16864649
• Report Number: 2523676-2023-00134
• Device Sequence Number: 5421189
• Product Code: OFU
• UDI-Device Identifier: 04046964317873
• UDI-Public: (01)04046964317873
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 560074
• Device Catalogue Number: 560074
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 04/18/2023; 04/18/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/30/2023; 07/31/2023; 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 104 KG