MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAFETY-LOK¿ INFUSION SET WITH FILTER; INTRAVENOUS CATHETER

Catalog Number	47260025
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported before use of the bd intima-ii catheter upon visual inspection there were tears observed on two primary packages of the infusion set of the final packaged product there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: 4 pictures were sent of safety lok infusion set product 47260025 with lot number 7153961.According to issue stated by customer ¿holes, cracks or tears on blister¿.Review of dhr was performed for lot number 7153961 for holes, cracks or tears on blister issues and they were not found during the packaging inspection process of the material packed.Pictures analysis under normal visual inspection shows the reported attribute, hole/ tears on package on 4 of the 4 pictures received but these conditions were not confirmed and could not be reproduced on the packaging process, this could be caused at the customer repackaging process.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The customer complaint was not confirmed and could not be reproduced on the packaging process, this could be caused at the customer repackaging process investigation conclusion: root cause analysis revealed the mostly probable cause is the packaging process at the customer site during the repack process of the blister on their kit.

• Brand Name: BD SAFETY-LOK¿ INFUSION SET WITH FILTER
• Common Device Name: INTRAVENOUS CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7200165
• Report Number: 9610847-2017-00242
• Device Sequence Number: 11020181
• Product Code: FOZ
• UDI-Device Identifier: 00382904726003
• UDI-Public: 00382904726003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 47260025
• Device Lot Number: 7153961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other