MAUDE Adverse Event Report: GREATBATCH MEDICAL MOBICATH BIDIRECTIONAL GUIDING SHEATH, LARGE CURVE; INTRODUCER, CATHETER

Model Number	1000182-002
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two complaints were received regarding the mismatching of labels.For the subject incident, it was observed that the pouch label correctly stated it was a large curve sheath but the box label incorrectly stated it was a small curve sheath.The other incident is from the same lot (reference mdr 2183787-2016-00051).However, with this incident the box label correctly stated it was a large curve sheath but the pouch label incorrectly stated it was a small curve sheath.Lot and model information were consistent among the two sets of labels.It is expected that the devices will be returned from the distribution centers.An investigation is on-going into the cause and impact of the labeling mismatch.A follow-up mdr will be submitted once the investigation is complete.
Event or Problem Description
The description on the product packaging is not correct.It shows small curve but it should be large curve, the item number and lot are correct.The issue was noticed at the product distributor's distribution center.There was no patient involvement.
Additional Manufacturer Narrative
Two complaints were received regarding the mismatching of labels.For the subject incident, it was observed that the box label correctly stated it was a large curve sheath but the pouch label incorrectly stated it was a small curve sheath.The other incident is from the same lot (reference mdr 2183787-2016-00051).However with this incident the pouch label correctly stated it was a large curve sheath but the box label incorrectly stated it was a small curve sheath.Lot and model information were consistent among all labels.In both incidents, the incorrect labeling was detected prior to use.Complaints were reviewed and found this to be a first occurrence for a label indicating the incorrect product curve.The investigation determined that the root cause was due to a labeling deficiency.Corrective actions have been implemented.In addition, if the malfunction were to reoccur, it would not likely cause or contribute to a death or serious injury.Conclusion code updated based on investigation results.

• Brand Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH, LARGE CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane n; minneapolis MN 55441
• MDR Report Key: 5718326
• Report Number: 2183787-2016-00050
• Device Sequence Number: 18973787
• Product Code: DYB
• UDI-Device Identifier: 10846835012378
• UDI-Public: (01)10846835012378(17)170211(10)W3351374
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2016

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: 02/11/2017
• Device Model Number: 1000182-002
• Device Catalogue Number: D140011
• Device Lot Number: W3351374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2016
• Supplement Report FDA Received Date: 08/23/2016
• 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