MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN 0,9 X 25MM; INTRAVASCULAR CATHETER

Catalog Number 38833514

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the batch and expiration date were missing on 5 angiocath 22ga x 1,00in 0,9 x 25mm labels before use.The following information was provided by the initial reporter, translated from (b)(4) to english: "reason: 5 packages of catheter are empty, sealed and without product.Product: intravenous peripheral catheter angiocath, batch: not described in secondary package, expiration date: not described in secondary package".

Manufacturer Narrative

H.6.Investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record could not be performed as the reported lot was unknown.Our quality engineer reviewed the provided photo and observed that the package was empty.Based off the provided photo the engineer was able to verify the reported defect.It was determined that this was an operator error that occurred during the packaging process.The manufacturing facility has been notified of this incident and the findings.A training was issued for all packaging personnel to raise awareness of this issue and prevent recurrence.H3 other text : see h.10.

Event Description

It was reported that the batch and expiration date were missing on 5 angiocath 22ga x 1,00in 0,9 x 25mm labels before use.The following information was provided by the initial reporter, translated from portuguese to english: "reason: 5 packages of catheter are empty, sealed and without product.Product: intravenous peripheral catheter angiocath batch: not described in secondary package.Expiration date: not described in secondary package".

• Brand Name: ANGIOCATH 22GA X 1,00IN 0,9 X 25MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10625572
• MDR Text Key: 211010784
• Report Number: 9610048-2020-00138
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38833514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other