MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

Catalog Number 309649

Device Problem Defective Device (2588)

Patient Problem Blurred Vision (2137)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd plastipak¿ luer-lok¿ syringe there was an issue with blurred double vision with the scale markings.

Manufacturer Narrative

Correction: describe event or problem: it was reported that the scale printing on 216 of the bd plastipak¿ luer-lok¿ syringe had blurred/double-printed numbers and graduation lines.There were other occurrences on different dates captured in related complaints.Investigation summary: three photos were received and evaluated.Each photo depicted a 5ml syringe filled with clear liquid and a tip cap attached.It is unknown which batch each sample in the photos belongs to.Additional 6 photos were received.The photos showed filled 5ml syringes with blue tip caps attached.The barrels had varying degrees of missing print, primarily in the first few grad lines close to the zero line.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.Machine logs indicate adjustments at printer were recorded during the manufacture of batches 8128506.Out of the 7 batches provided, 5 were manufactured at our plant 8128506, 8145680, 8222764, 8119614 and 8119628 ¿while the other two are not in our system.Investigation conclusion: photo 1 and 2 both showed blue capped syringes with slight double print of the scale markings visible.The double print observed was lateral only.The items were still legible and volumetric accuracy not compromised.The print observed is acceptable per product specification.Photo 3 showed a red capped syringe with a lateral double print visible.The double print observed created clearly visible doubling of numbers and is rejectable per product specification.2 out of the 6 photos provided showed rejectable missing print, while 4 had acceptable print per product specification.The rejectable samples showed over 50% of at least one item, such as graduated line or number, missing.The acceptable samples all had small amounts of print missing with less than 50% of any one item missing and all of the items legible.The scale was still legible in these cases.Root cause description: based upon the pictures and the batch numbers provided we believe that this print defect is associated with one single batch since the defect appears to have worsened over time.Perhaps the mixing of bd lots at the facility could explain the involvement of 7 batches with this issue.Customer confirmed they utilize the fifo process.If during the picking process a manufacturing lot number is depleted they would utilize an additional manufacturing lot number.This would cause the batch numbers to sometimes use multiple manufacturing lot numbers of syringes.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the scale printing on 216 of the bd plastipak¿ luer-lok¿ syringe had blurred/double-printed numbers and graduation lines.There were other occurrences on different dates captured in related complaints.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8186862
• MDR Text Key: 131140761
• Report Number: 1213809-2018-00899
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 309649
• Device Lot Number: 8128506
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other