MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number	305006
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Two used device samples without sheath components and blister packaging were returned for analysis.Specifically, sample #1 was one used catheter assembly without severed catheter tube and needle guard assembly, and sample #2 was one used 22g catheter assembly with detached, locked out needle guard assembly.Magnified examination of the catheter assemblies displayed evidence of a puncture in the catheter tube at approximately mid-length consistent with the "j" shape profile of the introducer needle, resulting in severance for sample #1, with no evidence of damage/mechanical witness marks on catheter hub or tube tears within the catheter hub.Sample #2 displayed no evidence of catheter bevel tip irregularities.This "j" shape incision in the catheter tube length of each sample was consistent with catheter wall penetrations by the cannula as a result of a redirect during insertion and not the result of a manufacturing nonconformance.Examination of sample #2 needle guard assembly displayed normal flash in the flashback chamber with no evidence of locking mechanism damage, cannula protrusion beyond guard nose or cannula tip damage.Examination of the photos of the catheter assemblies against manufacture technical report for investigation into causes of catheter severance failure modes suggested the reinsertion of the needle into the catheter sheared/punctured the catheter tubing.Based on device analysis, the reported event was determined to be due to a variation in insertion technique.Per instructions for use (ifu) section 4.2, the introducer needle must not be reinserted inside the catheter once the needle has been partially or completely withdrawn as it may pierce the catheter.Premature removal of the introducer needle from the catheter can result in catheter shear upon insertion as reported by the complainant.The catheter is thin wall by design and needs the needle in order to thread properly into the vessel, with the needle acting as a guide wire during the process.It is important to note that catheter severance can be attributed to practices not supported by the infusion nurses society standards of practice.These types of practices include, but were not limited to, reinsertion of the needle during initial intravenous (iv) placement.In order to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tube, and hub) are tightly controlled.During the manufacturing process, our catheters were tested to assure that the tubing would not tear, break or otherwise fail.During the manufacture, critical parameters were 100% controlled during the different phases.Once the catheters were assembled from the tube, eyelet and hub, the catheters were inspected in-process 100% in order to demonstrate that the catheter tube was properly secured to the hub.In process, product was accepted based on meeting specification requirements.If any nonconformances were found in process, the product was isolated, non-conformed and immediate action was taken to perform corrections.Inspections and tests were conducted by trained operators using statistically valid sampling plans at defined intervals.Sampling plans were based on random sampling selection and are designed to provide a high level of assurance that the true fraction defective was less than or equal to the established acceptance quality limit (aql) level for each quality characteristic.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Manufacturing regularly reviews and analyzes post-market data for new information or adverse trends.
Event or Problem Description
It was reported that the needle stuck in patients hand.No additional adverse patient effects.This event was considered a serious injury.Received additional information stating a needle was not stuck in child's hand, it was 3/4 of the plastic intravenous (iv) catheter that was retained in the child's hand until a general surgeon was able to safely remove.

• Brand Name: JELCO SAFETY PROTECTIV CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17009157
• Report Number: 3012307300-2023-05662
• Device Sequence Number: 7031534
• Product Code: FOZ
• UDI-Device Identifier: 10351688071118
• UDI-Public: 10351688071118
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: 305006
• Device Catalogue Number: 305006
• Device Lot Number: 4226848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 MO
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White