MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	305540
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 305540 , batch# 2304613.It was reported that the bd syringe allergy 1ml w/ndl 27x1/2 rb packaging was damaged/defective.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.We received a customer complaint on 23may24 for 46 trays of 1cc, 27g x ½, syringes (item# bd5540, lot# 2304613), stating ¿syringes are melted to packaging¿.The customer returned the product on (b)(6) 2024.One box with 5 unopened trays and one open tray and one case containing 40 unopened trays were returned.Please provide a prepaid return label to forward the reported product to you.Can you please initiate an investigation and forward your findings to me.We have assigned complaint number (b)(4) to this complaint.Please reference this complaint number in all future correspondence.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: 5 photos and 26 trays were received for investigation by our quality team.One "opened" tray was received with a syringe crimped and fused into the corner were the seal meets plastic.The complaint has been verified and the root cause of this issue is due to improper tray loading that led seal to seal other a syringe and cleave it.This issue is a quality control deficiency because the defect should have been noticed during visual checks.Corrective actions are not possible because the production facility for the device's production has since closed.No issue was present in the packaging of any other trays.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue (batch# 2304613).
Event or Problem Description
Samples received.

• Brand Name: BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19606041
• Report Number: 1920898-2024-00133
• Device Sequence Number: 6236729
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: (01)00382903055401
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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 Catalogue Number: 305540
• Device Lot Number: 2304613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown