MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI-SPIKE; SET, I.V. FLUID TRANSFER

Model Number	412012
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported by the user facility: it was reported that brown residue was observed on the spike.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample in open packaging identifying reported lot 61775128 was returned for evaluation.Visual evaluation of the sample confirmed various dark embedded specks identified as burnt resin (die drool) in the guard.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.As a result of this occurrence, a new work instruction for 100% inspection for black particulates during manufacturing and packaging for this product was initiated.If additional pertinent information becomes available a follow-up report will be filed.Note: section g2 was updated to include that (b)(4) was also received for this report.

• Brand Name: MINI-SPIKE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 12306405
• Report Number: 2523676-2021-00249
• Device Sequence Number: 14373081
• Product Code: LHI
• UDI-Device Identifier: 04022495769671
• UDI-Public: 04022495769671
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 412012
• Device Catalogue Number: 412012
• Device Lot Number: 0061775128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1