MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 26 G (1.9 FR) X 1.9 CM BD INTROSYTE-N¿ PRECISION INTRODUCER; INTERVASCULAR CATHETER

Catalog Number 384021

Device Problem Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: event description: during the installation of vvc (peripheral venous pathway), the introduction remained blocked in the vein and caused a rupture in the vein and a large hematoma.Once removed from the child¿s arm, the end of the introducer is twisted, bevel in the air.Device/batch history record review: yes findings: review of dhrs revealed all required samples and testing was conducted per specifications and in accordance with the in-process sampling plans.Review disclosed no related reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the investigation.Inspection plan for attributes (orientation, damage) and in process inspections (penetration and drag) were performed and passed per specification qn / sap database review: no.Reason: qn/sap review is not required for level a investigations as per (b)(4).Findings: n/a.Visual analysis: observations and testing: received on bd introsyte-n precision introducer 1.9f inside a specimen container, the unit was heavily soiled with patient residue (blood), observed the unit revealed the needle had speared through the peel away tubing (see photo (b)(4)).Visual/microscopic examination: observed the needle had speared through the peel away sheath tubing (see photo (b)(4)).Observed the needle, the sheath tip and the end of the hub had traces of blood (evidence of insertion).The needle tip would have formed a ¿v shaped cut¿ (by spearing through the tubing) near the tubing tip if the skive line was not partially started to split.The tubing sheath tip was damaged (sheared/jagged edge).The bevel of the cannula was well oriented.Test description: visual/microscopic; method no: n/a; results: see observations and testing.Investigation samples(s) meet manufacturing specifications: no.The unit was received with the needle tip speared through the catheter sheath leaving a v shaped cut.Investigation conclusion: the unit was received with the needle tip speared through the catheter sheath.Root cause description: indeterminate.In relation with the ¿v shaped¿ cut found on the catheter sheath and the catheter sheath tip (jagged edge): it is uncertain if the damage observed was caused by manipulation of the device prior/during insertion or by the manufacturing process.Where the defect occurred (user or manufacturing) is indeterminate as the unit received had been used.Comment: patient residue observed within the unit indicates the needle and catheter were correctly assembled at the time of use.The extent of damage to the tubing exhibited with the returned unit would have been observed during the insertion process by the clinician.Insertion would not be possible due to the condition of the returned used unit.The condition would have created resistance for insertion of the catheter.Note: a 100% visual examination is performed at various stages of the process during the manufacturing of the product.100 percent visual inspection of each package and components for quality, general appearance and damage, is performed before placing them into shippers by an individual inspector in preparation for sterilization.A root cause could not be established.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.Other action taken: product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.These inspections are performed by operators and/or process control technicians to ensure any gross process changes are identified.If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.The peura (end user risk analysis) rm5863 rev 4.0 was analyzed to determine the risk to customer.The analysis showed that due to low severity, current risk is acceptable.

Event Description

It was reported that the 26 g (1.9 fr) x 1.9 cm bd introsyte-n¿ precision introducer was difficult to thread and caused a hematoma.Once removed the bevel twisted up into the air.Found during use.No serious injury or medical intervention noted.

Manufacturer Narrative

Results: bd received one sample unit from the customer for evaluation by our quality engineer team.Upon examination, it was observed that the needle had speared through the tubing and the bevel of the cannula was well oriented.The samples were visually and microscopically evaluated and the customer's indicated failure mode for leakage with the incident lot was observed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported issues.It is uncertain whether the damaged catheter sheath was caused by manipulation of the device during insertion or by the manufacturing process.The residue observed within the unit indicates the needle and catheter were correctly assembled at the time of use.The extent of the damage to the tubing exhibited with the returned unit would have been observed during the insertion process by the clinician.Insertion would not be possible due to the condition of the returned unit.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode for needle through catheter.However, bd was unable to duplicate or confirm the customer's indicated failure mode for needle bevel orientation incorrect, hematoma and catheter difficult to remove.The root cause is indeterminate.

• Brand Name: 26 G (1.9 FR) X 1.9 CM BD INTROSYTE-N¿ PRECISION INTRODUCER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7068900
• MDR Text Key: 94199542
• Report Number: 1710034-2017-00463
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 384021
• Device Lot Number: 5055718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2015
• 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
• Patient Outcome(s): Other