MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL BNS; PISTON SYRINGE

Catalog Number 301027

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: six photos, one drawing and two loose 5ml syringes were received and evaluated.Two photos displayed a loose 5ml syringe with collar flash.A note was in the photo stating the flash measured 0.0068 inch in vertical length, which was acceptable per product specification.Two photos displayed a loose 5ml syringe with tip flash.The tip flash appeared to be minimal, but the length could not be determined based on the photos.Two photos each displayed a single loose 5ml syringe that appeared to match the physical samples received.It was observed one syringe had the "1" and "2" numerals missing and one syringe had portions of grad lines and numbers missing throughout the scale.Both syringes were rejectable per product specification.The drawing received appeared to be outdated with no drawing number referenced to compare the current revision.Potential root cause for the tip and collar flashing defects are associated with the molding process.Potential root cause for the missing print defect is associated with the marking process.Since the tip and collar flash defects observed appeared to be within the acceptable limits, no corrective actions are necessary.No corrective actions are necessary for missing print based on the defective rate identified.Batch 0055516 is considered in compliance with our product specification requirements.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that an unspecified number of syringe 5ml ll bns had sharp molding defects before use.The following was reported by the initial reporter: "it was reported dirt, incomplete printing, faded/light printing, flash, and dimensional issues.Verbatim: per customer's response 4/20/2021 according to the response, the customer received 50 pieces, as defect in 50 each? please confirmed this number - as previously stated, 18% of 50 pieces purchased were rejected due to dirt, incomplete printing, faded/light printing, flash, and dimensional issues (i do not know the breakdown by nonconformance).18% so, 9 pieces were rejected out of the 50 pieces received.Please press for answer to dimensional issues.It is not clear that product does not meet drawing.Which specific part of the drawing is in question? this not something i can press the customer for at this point.The drawing i provided is the drawing (b)(6) received from bd.Is it an accurate and correct drawing based on the parts (b)(6) currently receives from bd? per customer's response 04/19/2021 what we need is for every complaint and defect to request: - unused samples representative of that defect.Already sent to the bd  balance are at the suppliers overseas - how many were found for each reported defect per batch.18% of 50 pieces purchased were rejected due to dirt, incomplete printing, faded/light printing, flash, and dimensional issues (i do not know the breakdown by nonconformance).- were the defects found at incoming inspection or during processing? yes, the nonconformities were found during incoming inspection.- what was the inspection quantity for each defect? 100% of the 50 pieces received - what was the total quantity for each batch received by the customer? 50 pieces in addition follow up in regards to the meaning of dimensional issues what is meant by "dimensional issues?" we need specifics and unused samples for dimensional issue to better investigate.The customer has clarified and stated that the parts do not meet the drawing  no further specification (see drawing below) (see the drawn explanation attached to the e-mail) md.As per my earlier email, here is another one of the cases that i mentioned.Our customer has reported receiving nonconforming pieces of bd part number 301027, (b)(6) part number c3305, bd" syringe, male luer lock 5ml.Your batch number is 0055516.The customer is finding an 18% rejection rate due to dirt, incomplete printing, faded/light printing, flash, and dimensional issues.".

• Brand Name: SYRINGE 5ML LL BNS
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11817419
• MDR Text Key: 252335968
• Report Number: 1213809-2021-00315
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301027
• Device Lot Number: 0055516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1