MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYRINGES,DISPENSERS; DISPENSER, LIQUID MEDICATION

Catalog Number 624887

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was an ink smear on the dosing demarcations of up to seven hundred (700) syringes.It was further reported that the smears were at the 3.2 ml mark.This issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to b5, d10, h3, h4 and h6.B5: the customer reported there were a total of 2,102 nonconforming units (previously reported a quantity of up to seven hundred (700) syringes).H4: device manufactured in march 2020.H10: five (5) devices were received for evaluation.The remaining 2,097 were not received and therefore could not be evaluated.Unaided eye visual inspection was done on the returned samples which observed smeared print at the 3.2 ml / 3.3 ml graduation area of samples 1 through 4 and missing print at the 2.5 ml graduation area of sample 5.No functional testing was performed for this complaint.The reported condition was verified.The cause of the condition was determined to be due to a supplier manufacturing issue.A batch review was conducted and during manufacturing, ink spots were found on the cylinders.To correct this issue, two bags were discarded after inspection.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SYRINGES,DISPENSERS
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10265094
• MDR Text Key: 198573232
• Report Number: 1416980-2020-03954
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 00682126242573
• UDI-Public: (01)00682126242573
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 624887
• Device Lot Number: H88559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1