MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number	383346
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9057759, medical device expiration date: 2023-02-28, device manufacture date: 2019-04-01.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system had "resistance" when the nurse attempted to pull back the needle after use, until it "snapped back", piercing through the shield and resulting in a dirty needle stick.Blood testing was done on the nurse, as well as the source patient.Lot# 9057759 was reported to have had 1 occurrences of this event, while an unspecified lot was also reported to have been involved in this event, but it is unknown how many occurrences happened within it.The following information was provided by the initial reporter: "basically what happened is the rn started an iv and when she tried to pull back the needle she met resistance.She pulled harder to get the needle out and when she did it snapped back and went through the plastic sheath resulting in a needlestick." "staff member had blood work performed as a result and "(and also source patient).".
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system had "resistance" when the nurse attempted to pull back the needle after use, until it "snapped back", piercing through the shield and resulting in a dirty needle stick.Blood testing was done on the nurse, as well as the source patient.Lot# 9057759 was reported to have had 1 occurrences of this event, while an unspecified lot was also reported to have been involved in this event, but it is unknown how many occurrences happened within it.The following information was provided by the initial reporter: "basically what happened is the rn started an iv and when she tried to pull back the needle she met resistance.She pulled harder to get the needle out and when she did it snapped back and went through the plastic sheath resulting in a needlestick." "staff member had blood work performed as a result and "(and also source patient).".
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for the one provided lot number, 9057759.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To further investigate this issue, seven unused samples were provided for evaluation by our quality engineer team along with picture samples.Each of the seven physical samples were tested for pull force and all of the samples were found to be within specification.No defects were observed on the seven physical samples.Based on an evaluation of the picture samples, it was determined that the defect was possibly related to the activation of the device.If the user incorrectly activates the device and only partially retracts the needle, the needle makes a memory pattern within the tubing, which results in a "sling shot" like motion, sending the needle to the original position and resulting in damaged or pierced tubing.Based on the investigation results, a definite cause related to the manufacturing process could not be determined for this reported incident.H3 other text : see h.10.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9746939
• Report Number: 9610847-2020-00057
• Device Sequence Number: 11460063
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 383346
• Device Catalogue Number: 383346
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/23/2020
• 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