MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ IV CATHETER 24GAX0.75 IN; INTRAVENEOUS CATHETER

Catalog Number 383408

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation: as sample has been returned to the manufacturer.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that bd intima-ii¿ iv catheter was placed (b)(6) 2016 to the left forearm.It was not a repeat puncture and there was nothing abnormal noted during insertion or previous infusions and flushing.On (b)(6) 2016 at 9:30 am, the patient was getting undressed and found the catheter hub had detached from the insertion point but he didn't realize that the catheter had broken.At approximately 10:30 am, when the nurse was checking the ward and preparing the infusion for the patient, she found the iv was not on the patient's hand.The patient then returned the catheter hub to the nurse and she realized the catheter had broken.The patient received an x-ray and a full body ct scan but the missing catheter piece was not detected.Per assessment of the catheter remaining in the hub, the head nurse and doctor thought the broken section was smooth and they didn't believe the catheter could be damaged as a result of the patient undressing.The patient was discharged on (b)(6) 2016 without any further complaints or adverse symptoms.

Manufacturer Narrative

Device evaluation: result - a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5198307.One used sample without the original packaging was received for evaluation on 1/8/2016.Observation under microscope revealed the needle has been pulled out and the catheter is broken.The site of the catheter breakage is about 1.5mm from the catheter adapter.The broken section is not smooth, has a burr, and no obvious stretching is observed.Because the catheter of the returned sample is too short, inside diameter, outside diameter, and tension testing cannot be performed.Catheter pull testing was performed in a vertical direction on retention samples of the same lot number.The broken catheter section of the retention sample is different than the broken section of the returned sample.A pull test on a catheter which was pierced through by a needle was performed on retention samples of the same lot number.The broken catheter section shows an obvious v-shape, which is different than the broken section of the returned sample.A pull test on a catheter which was bent 20 times at 180 degrees was performed in the vertical direction on retention samples of the same lot number.The broken catheter section of the retention sample is again different from the returned sample.Conclusion- the defect was not found to be manufacturing related.Out-going inspection of the reported lot 5198307 is qualified.The separating force test between catheter and catheter adapter meets requirements.No similar defect as the returned sample was found after simulating three conditions which may lead to a broken catheter.From the complaint feedback, no abnormality was found during previous infusion and flushing so the complaint cannot be confirmed.The customer's reported defect may have been caused by the patient when undressing.

• Brand Name: BD INTIMA-II¿ IV CATHETER 24GAX0.75 IN
• Type of Device: INTRAVENEOUS CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5395248
• MDR Text Key: 36956356
• Report Number: 3006948883-2016-00003
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 383408
• Device Lot Number: 5198307
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR