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

Catalog Number 384008

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.Medical device lot #.The customer provided lot 11142412 however, this could not be verified as a valid lot number.(b)(4).It is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.See manufacturer narrative.

Event Description

It was reported that while attempting to place a midline catheter in the neonatal icu, the part of the introducer that gets torn in half and taken off in order to advance the catheter broke and wasn't able to be completely removed.The whole line had to be removed and the neonate stuck again.

Manufacturer Narrative

Device evaluation: result - one used 26g bd introsyte-n autoguard shielded introducer without packaging was received for evaluation.The unit consisted of the splittable sheath (split in two portions).Accompanying the unit was a label from an l-cath picc s/l ref.384539.A visual/microscopic examination was performed and it was observed that each portion of the peel-away sheath was broken at the tabs and partially peeled down the tubing.The peel-away sheath revealed stress and jagged edges to near midway of the tubing where the portion revealed separation by stress.The edges revealed that the break at the tabs occurred at the skive line on both tabs yet then deviated from the skive line on one side of the tubing.Examination revealed separation by stress resulted in jagged edges.The skive line was present on both sides of the peel away catheter tubing.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - confirmation of the defect as stated by the customer was conclusive with the used unit provided for this incident.The unit displayed the characteristics of jagged separation with stress along the peel and evidence of deviating from the skive line resulting in a jagged break at the peel away tubing.Based on the evaluation of the returned unit it was indicative that the cause of failure was induced by deviating from the skive line during the peel and stress to the unit in the clinical environment.

Event Description

The resource specialist for women & children reported this defect has happened more than once before.Chg was the solution used to prep the site.

• Brand Name: 26G (1.9FR) X 1.9CM BD INTROSYTE-N¿ AUTOGUARD¿ SHIELDED INTRODUCER
• Type of Device: NEONATAL, CATHETER INTRODUCER
• 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: 6202512
• MDR Text Key: 63224095
• Report Number: 1710034-2016-00067
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

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: Health Professional
• Device Catalogue Number: 384008
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention