MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THE

Model Number	N/A
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4) device history record review (dhr): reviewed the device history record and no abnormalities found during in- process and final control inspection.Investigation results: received 1 used contaminated cannula hub of introcan safety pur 22g, 0.9x25mm-ap without packaging.Capillary hub was not returned for investigation.The safety clip was in an engaged position.The returned sample was examined under a smartscope.No damages were observed on the safety clip and crimp area on the cannula.The safety clip was not deformed.No abnormality found in crimping area.Simulation for clip function: pushed back the safety clip to the cannula hub.Inserted the returned sample with a fresh capillary hub of g22 to simulate the clip function.After withdrawal, the safety clip was activated and able to cover cannula tip.Conclusion: the returned sample was tested and not abnormality observed.Dhr reviewed showed no deviation and the complaint batch passed clip functional test and visual inspection.Complaint is not confirmed.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in japan: needlestick injury (safety clip failure).
Additional Manufacturer Narrative
Exemption number e2016018.B.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical inc.Internal report number (b)(4).This follow up report is being filed to correct the branding, product code, and 510(k) information that was entered on the initial mdr in sections d1, d2, and g5.This report was filed for item number, 4251628-03, which is not sold in the united states, however a similar item number, 4251628-02, is sold in the united states by b.Braun medical, inc.The 510(k) has been updated to reflect a 510(k) that item 4251628-02 has been cleared under.Note: b.Braun is aware that the listed exemption has been withdrawn, however since the initial mdr report was filed under this exemption, the follow up is also being filed under the exemption.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7629321
• Report Number: 9610825-2018-00113
• Device Sequence Number: 2155296
• Product Code: FOZ
• UDI-Device Identifier: 04046964399091
• UDI-Public: (01)04046964399091(17)211101(10)16M16G8362
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019
• Report Date (Section F): 07/02/2019

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4251628-03
• Device Lot Number: 16M16G8362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/02/2019