MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE

Catalog Number	303134
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 10ml s/t 200 s/c had a scale marking issue.The following information was provided by the initial reporter: "syringes without graduation marking.".Verbatim: rcc received a complaint via email.Email(s) attached.I hope you are well.I am (b)(6), sqe from medtronic.This e-mail is to notify you about a quality event detected in our manufacturing process.The details are listed in the table below.Mdt part number.Description.Mdt lot.Impacted qty.Supplier lot.Po.Issue.M728424b001.Syringe 10 ml.0012051061; 0012173819.(b)(4) ea.(b)(4) ea.3206175 (b)(4) syringes without graduation marking.Pictures of the nonconformance: [cid:(b)(4)].Please help us with the following: *mitigation activities: includes review of stock/wip, lot number without the nonconformance on the next shipment to medtronic and confirm if the scope is only for the material reported or if there could be additional lots impacted by this nonconformance.Please let me know if you have any questions.Thanks in advance! (b)(6).Supplier quality engineer | (b)(4).Additional information provided on 04/09/2024: 1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.Dates of occurrences: 03/08/2024; 03/15/2024.2.Any physical sample available for investigation of affected product? if yes, are you able to provide the address of the facility for us to ship the return label? yes, we have 8 samples.Address: medtronic.(b)(4).
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
Eight sample and two photos of 10ml luer-slip syringes lot 3206175 were received and evaluated.Six of the samples were received loose and two in sealed packages.All product information was on the top web packaging.Both packaged samples and four loose samples are missing all or most of the scale markings, one sample has skewed scale causing most of the graduation lines to be missing, and one syringe has rolled scale with most of the numbers light print and barely visible.One photo shows a loose barrel missing all the scale markings and the other shows the skewed sale as described above.The condition observed is non-conforming per product specification.Potential root cause for the scale marking defects is associated with the marking process.A device history record review was completed for provided lot number 3206175 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
Materials#: 303134, batch#: 3206175.It was reported by the customer that the syringes without graduation marking.Verbatim: rcc received a complaint via email.I hope you are well.I am evelyn gil, sqe from medtronic.This e-mail is to notify you about a quality event detected in our manufacturing process.The details are listed in the table below.Mdt part number, description, mdt lot, impacted qty, supplier lot, po, issue, m728424b001, syringe 10 ml, 0012051061, 0012173819, 10 ea, 3 ea, 3206175, 4506718171, syringes without graduation marking.Pictures of the nonconformance: [cid:e4ba0717-b935-4107-a7c8-9f727166d06c].Please help us with the following: * mitigation activities: includes review of stock/wip, lot number without the nonconformance on the next shipment to medtronic and confirm if the scope is only for the material reported or if there could be additional lots impacted by this nonconformance.Please let me know if you have any questions.Thanks in advance! evelyn gil.Supplier quality engineer | sqa.Medtronic.

• Brand Name: BD SYRINGE 10ML S/T 200 S/C
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19122448
• Report Number: 1213809-2024-00235
• Device Sequence Number: 8230178
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 07/16/2024

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: 303134
• Device Lot Number: 3206175
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown