MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 6 FR 110CM; CATHETER, ELECTRODE RECORDING

Catalog Number AI-06225

Device Problem Expiration Date Error (2528)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For related complaints see mdr #3010532612-2018-00133 and tc #(b)(4) , mdr #3010532612-2018-00135 and tc #(b)(4), mdr #3010532612-2018-00136 and tc #(b)(4).

Event Description

It was reported that the expiration date exceeded the shelf life of the product.Over 60 months (5 years).The customer received a product with date of expiration 31dec2023.No patient involvement reported.

Manufacturer Narrative

(b)(4).For related complaints see mdr #3010532612-2018-00133 and tc #(b)(4), mdr #3010532612-2018-00135 and tc #(b)(4), mdr #3010532612-2018-00136 and tc #(b)(4).Teleflex did not receive the device for investigation.The reported complaint of component label/tag incorrect is confirmed.The packaging was noted with an incorrect expiration date printed on the label.A nonconformance and a capa has been initiated to further investigate the root cause.

Event Description

It was reported that the expiration date exceeded the shelf life of the product.Over 60 months (5 years).The customer received a product with date of expiration 31dec2023.No patient involvement reported.

• Brand Name: CATH PKGD: PACING 6 FR 110CM
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7516042
• MDR Text Key: 108800239
• Report Number: 3010532612-2018-00134
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: AI-06225
• Device Lot Number: 16F18A0026
• Other Device ID Number: 00801902002358
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1