MAUDE Adverse Event Report: HYCOR BIOMEDICAL SPECIFIC/TOTAL IGE EIA

Catalog Number	74155
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor reported the shipment containing stop solution (1n sodium hydroxide) was received with a stained carton, suggesting leakage of an item in the package.Photographic evidence provided by the distributor showed two stained cartons.Pictures of the stop solution bottles showed that one bottle had a visibly lower volume than the bottle from the other carton.Hycor requested products be returned for investigation.The investigation demonstrated one of the two returned bottles was leaking as determined by a vacuum test.Further investigation determined that the stop solution bottles used in the kit lot were manufactured during a time when the automatic capping system malfunctioned leading to a temporary process to hand tighten the caps.A stop ship order for product containing stop solution bottles manufactured during the time period when the capping system was not functioning correctly was initiated 05/31/2018.All impacted bottles of stop solution have been reprocessed ensuring that the cap is sealed with the proper torque.A sampling of product was tested in a vacuum chamber to determine if leaking was present, no leaks were detected.Hycor is initiating a recall action to inform distributors that leaking stop solution bottles have been reported during transit and that they should inspect remaining inventory for evidence of leakage prior to further distribution.There were no adverse outcomes reported to hycor.However, out of an abundance of caution, we are filing an mdr.Delay in reporting was due to an employee confusing this event with a previously reported similar event, review of records determined that this event should also have been reported.[(b)(4)].
Event or Problem Description
The distributor reported the shipment containing stop solution (1n sodium hydroxide) was received with a stained carton, suggesting leakage of an item in the package.Photographic evidence provided by the distributor showed two stained cartons.One carton was stained on the bottom panel, the second carton was stained on the top panel indicating that a bottle from one carton likely leaked and stained the lower carton.Pictures of the stop solution bottles showed that one bottle had a visibly lower volume than the bottle from the other carton.(the container is filled to 300 ml in a 500 ml bottle).Hycor requested products be returned for investigation.Hycor received the damaged products on 06/01/2018.The investigation demonstrated one of the two returned bottles was leaking as determined by a vacuum test.There were no adverse outcomes reported to hycor.However, out of an abundance of caution, we are filing an mdr.

• Brand Name: SPECIFIC/TOTAL IGE EIA
• Common Device Name: SPECIFIC/TOTAL IGE EIA
• Manufacturer (Section D): HYCOR BIOMEDICAL; 7272 chapman ave; garden grove CA 92841
• MDR Report Key: 7679461
• Report Number: 2016473-2018-00002
• Device Sequence Number: 19020561
• Product Code: DHB
• UDI-Device Identifier: 00816879022100
• UDI-Public: (01)00816879022100
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 74155
• Device Lot Number: 154104-9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1