MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH IV CATHETER 18GA 1.16IN; INTRAVASCULAR CATHETER

Model Number	381144
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number:(b)(6).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 54 bd angiocath¿ iv catheters 18ga 1.16in had a damaged package which compromised the sterility of the product.The following information was provided by the initial reporter: "some catheter # 18 packages have came open, apparently the glue does not make it adhere correctly and this caused them to come off easily, a situation that affects us both medically and financially, since if it has an open space, it loses its sterility and therefore cannot be used.These belong to batch 6292244 with expiration date 10/31/2021.Anyway, a check is done on the rest of the lot (inside their box, still without being handled) and some are open, and others are poorly sealed that are difficult to notice by rear visual inspection, in total there are 54 units compromised of this batch.".
Additional Manufacturer Narrative
H.6.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
Event or Problem Description
It was reported that 54 bd angiocath¿ iv catheters 18ga 1.16in had a damaged package which compromised the sterility of the product.The following information was provided by the initial reporter: "some catheter # 18 packages have came open, apparently the glue does not make it adhere correctly and this caused them to come off easily, a situation that affects us both medically and financially, since if it has an open space, it loses its sterility and therefore cannot be used.These belong to batch 6292244 with expiration date 10/31/2021.Anyway, a check is done on the rest of the lot (inside their box, still without being handled) and some are open, and others are poorly sealed that are difficult to notice by rear visual inspection, in total there are 54 units compromised of this batch.".

• Brand Name: BD ANGIOCATH IV CATHETER 18GA 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10067094
• Report Number: 9610048-2020-00077
• Device Sequence Number: 2826740
• Product Code: FOZ
• UDI-Device Identifier: 30382903811442
• UDI-Public: 30382903811442
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 10/31/2021
• Device Model Number: 381144
• Device Catalogue Number: 381144
• Device Lot Number: 6292244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/08/2020
• 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: Other