MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that saf-t-intima w/y adapter gn 18ga x 1.0in had foreign matter on the tip.This occurred on 5 occasions.The following information was provided by the initial reporter: after the nurse opened the package and removed the guard cap, it was found that there were unidentified objects, similar to gelatinous objects, on the tip of one catheter tube and the catheter tube wall of two indwelling needles.The customer did not use the needle at last and expressed doubts about the quality control of bd.Similar incidents had happened many times before.
Additional Manufacturer Narrative
H6: investigation summary : a complaint of foreign matter was received from the customer.Samples were returned for investigation of this defect.Through visual inspection the customer complaint was confirmed.With further testing the foreign matter was determined to be silicone used during the manufacturing process.Silicone is applied to the finished product to aid in the insertion of the device by the end user.The silicone is medical grade silicone and is safe.This product is made manually and during the assembly process and packaging area, product quality is evaluated during the manufacturing process with attributes inspections.This inspection is performed 100 % by operators to ensure that the product met with acceptance criteria.Besides, control technicians also perform a sampling according to the quality control plan.Dhr was reviewed for provided lot 9326780 and no qn¿s or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.H3 other text : see h10.
Event or Problem Description
It was reported that saf-t-intima w/y adapter gn 18ga x 1.0in had foreign matter on the tip.This occurred on 5 occasions.The following information was provided by the initial reporter: after the nurse opened the package and removed the guard cap, it was found that there were unidentified objects, similar to gelatinous objects, on the tip of one catheter tube and the catheter tube wall of two indwelling needles.The customer did not use the needle at last and expressed doubts about the quality control of bd.Similar incidents had happened many times before.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN
• 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: 11617300
• Report Number: 9610847-2021-00134
• Device Sequence Number: 11586140
• Product Code: FOZ
• UDI-Device Identifier: 00382903833467
• UDI-Public: 00382903833467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 383346
• Device Lot Number: 9326780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1