MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STERILE EMED DISPENSING PIN; SYRINGE, PISTON

Catalog Number	H93847
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the packaging of an unspecified quantity of dispensing pins had an oily effect on the paper backing (packaging).It was further reported the packaging on each unit was partially see-through and discolored (similar to if oil had contacted the paper).This was noted prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information : the lot was manufactured from august 22, 2019 - august 26, 2019.Thirty-one (31) cases of unopened samples were received for evaluation.Unaided visual inspection was performed on the two (2) randomly selected cases which observed a discolored dark texture on the back primary off all samples inside the cases.There was no discoloration issues inside the sterile pouch or on the product.The primary packaging of one (1) randomly selected sample was opened from each pair of cases and no contamination was observed of the sample.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: STERILE EMED DISPENSING PIN
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9862932
• Report Number: 1416980-2020-01611
• Device Sequence Number: 2874769
• Product Code: FMF
• UDI-Device Identifier: 00085412476575
• UDI-Public: (01)00085412476575
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K872743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: H93847
• Device Lot Number: 60202901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1