MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 1ML ST BULK CONVENIENCE PAK

Catalog Number	309701
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 1ml st bulk convenience pak had scale marking issue it was reported by customer that illegible markings on the barrel, rendering verbatim: rcc received a complaint via email.Email(s) attached my team reported that the bd 1ml slip tip syringe ref (b)(4) had illegible markings on the barrel, rendering it unsafe to use.The syringe has not been wiped with any solvent, it came out of the package as shown.The syringe was not used, no patients have been involved in an incident with these syringes.It was reported prior to use.Please see photos attached.Best regards, (b)(6) bsch, bscphm coordinator, pharmacy services - st.Joseph's hospital tel: (b)(6) (b)(6).
Additional Manufacturer Narrative
Our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of scale marking issue was confirmed upon inspection of the sample photos.Analysis of the sample photos showed that most of the scale markings on the syringes were grossly smeared.Bd determined that the cause of the failure was associated to our marking process.Since this defect is occurring below our expected frequency, no further corrective actions will be made at this time.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
1.What is the date of event? april 16, 2024 2.Please share the & lot number? lot 3212533, exp 2027-10-31 3.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? i have the affected syringe.The address is (b)(6).

• Brand Name: BD SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; colosio no. 579; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19321079
• Report Number: 9610847-2024-00124
• Device Sequence Number: 18054520
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: (01)30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/26/2024

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: 309701
• Device Lot Number: 3212533
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown