MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT UNIVERSAL PLUS-HAND CTL PISTO; UNIV. PLUS/MULTI-FUNCTION INST

Catalog Number	60-6010-002
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unused device was returned in original unopened packaging for evaluation.Visual inspection verified the reported "damaged" packaging anomaly as stress marks were noted on the tray and in the seal area.Further evaluation by way of dye leak testing was performed by a packaging engineer and the visual channels noted caused a breach of sterility.This packaging issue likely occurred during shipment and handling.The manufacturing documents from the device history record was reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.A two-year historical complaint review revealed 4 prior complaints involving 3 devices for this device family and failure mode.In this same timeframe, (b)(4) units have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent.This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.The instructions for use (ifu) provides the following warning.If packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor in (b)(6) rejected one (b)(4) device for "damage- sterile pouch/blister package".In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user.This report is raised on the basis of a device malfunction with potential for injury with recurrence.

• Brand Name: UNIVERSAL PLUS-HAND CTL PISTO
• Common Device Name: UNIV. PLUS/MULTI-FUNCTION INST
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• MDR Report Key: 7027412
• Report Number: 3007305485-2017-00249
• Device Sequence Number: 13776072
• Product Code: GEI
• UDI-Device Identifier: 00653405011708
• UDI-Public: (01)00653405011708(17)210511(30)1(10)201605124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: No Information
• Device Expiration Date: 05/11/2021
• Device Catalogue Number: 60-6010-002
• Device Lot Number: 201605124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1