MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD SYRINGE 10ML REG PR SALINE FILL SPKG; SALINE VASCULAR ACCESS FLUSH

Catalog Number	306553
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml reg pr saline fill spkg barcode scanned expiration date was beyond the pouch labeled expiration date.The following information was provided by the initial reporter: we¿ve found through the course of dispensing that at least 2 lots of this item have an expiration date in the barcode that is different from that printed on the product.The printed expiration date is 3/31/2026 but the barcode returns 3/26/2031.The barcode in the screenshot is: ]d2010038290306553017310326103110715.According to the dcsca support group the portion in bold is the expiration date and it should read 260331.Please let us know if we have to quarantine supply.I think it¿s quite likely that our entire on hand inventory is affected.We only started scanning 2d barcodes last week so we can¿t say when this started but it may have been going on for some time.Additional information received on 02-nov-2023 ¿ any other lot's# identified with the same issue? not yet.These two lots are the only ones we have in stock.¿ what is the date when the event was discovered? (b)(6) 2023.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.
Event or Problem Description
Additional information received on 22-nov-2023.This is the barcode scan results.]d2010038290306553017310326103110715.The portion in bold and underline is the date stamp.We feel this date is formatted yymmdd while we¿re expecting it to be ddmmyy.Thus, the expiration date is parsing incorrectly.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot numbers 3110715 and 3096557.The review did not reveal any possible non-conformances during the production processes that could have contributed to this reported incident.To aid in the investigation of this issue, one (1) picture sample and two (2) physical samples were returned for evaluation by our quality team.Both of the physical samples received were still within their original packaging.The barcodes on both samples were scanned using the microscan lvs barcode verifier.The results showed that the expiry date string was in the incorrect formation, reading ddmmyy when it should read yymmdd.The incorrect date format resulted from an error in the print recipe in the bellmark system.A corrective and preventive action plan has been initiated to rectify this issue.

• Brand Name: BD SYRINGE 10ML REG PR SALINE FILL SPKG
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18171274
• Report Number: 9616657-2023-00051
• Device Sequence Number: 7567897
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: (01)30382903065531
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K042061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 03/31/2026
• Device Catalogue Number: 306553
• Device Lot Number: 3096557
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown