MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Catalog Number	UPICDS-5.0-CT-OTW-ST-1110
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: microclave, simple obturator, infuser doran, seringue luer 20ml medicina, infuser baxter.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a turbo-ject power injectable picc line placed on (b)(6) 2018 was found to be blocked on (b)(6) 2018.This reported "blockage" occurred inside the white hub itself.A photograph provided by the customer shows it is no longer possible to attach/screw the hub onto another device.The picc line remained in use (purple lumen) as the patient was scheduled to complete their antibiotic treatment on (b)(6) 2018.Following the completion of treatment, the device was removed and disinfected.A more in depth visual inspection was completed by the customer whom stated a male element seems broken inside the hub (syringe or infuser).As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was originally reported that a turbo-ject power injectable picc line placed on (b)(6) 2018 was found to be blocked on (b)(6) 2018.In a correction to the original description, the picc line blockage was found on (b)(6) 2018.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailabl investigation evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history records, drawings, the instructions for use, and quality control data.The complainant returned one catheter manifold assembly in a used condition for investigation.Physical examination of the returned device showed there was no surface damage along the device or at the proximal hubs.The hubs were not cracked or separated.The correct luer threading was observed on both hubs.A syringe was able to connect to the purple hub.A syringe was not able to be connected to the white hub because it was blocked by an excess material within the hub.Dimensional analysis confirmed that the device had been manufactured within the correct specifications and tolerances.Investigators were able to recreate the reported failure mode, because a syringe could not connect to the hub.This was not due to the hub of the device, however, and was due to the material that was blocking the interior of the hub.Destructive testing was performed on the device to remove the blockage from the interior of the hub for observation.The material cracked when removed from the hub, but was confirmed to be a rigid, hard material.This confirmed that another device that had been connected to the hub appeared to have broken off.A review of the dhr for lot 8972289 and the two associated subassemblies showed there no non-conformances.A review of complaint history revealed there have been no other complaints associated with the complaint device lot # 8972289.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: catheter maintenance: after catheter placement and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip position should be immediately reevaluated by physician.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with a catheter locking solution.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated volume using normal saline before reestablishing catheter lock.How supplied: upon removal from package, inspect the device to ensure no damage has occurred.Cook has concluded that a portion of an externally connected device breaking off within the white hub during use contributed to this incident.The customer listed multiple devices that had been connected to the catheter after placement.It is likely that during an injection or flushing process, a portion of the connected device broke and remained within the hub.This blocked the lumen and would not allow other external devices to connect to it.Also, since it had been in place for approximately one month prior to the realization of the blockage, it is not likely that the failure occurred during the actual placement of the device.It is unknown how frequently the white hub was used, but the customer stated that multiple antibiotics (amoxicilline, amoxicilline /acide clavulanique, ceftriaxone) had been injected through it.According to the ifu, the device is flushed before and after the administration of different infusates.This suggests that multiple syringes and/or external devices were used while the device was in place.The customer further confirmed that the syringes and microclaves used while the device was in place were not supplied by cook.The complaint was confirmed based on the returned device.The likely conclusion is cause traced to maintenance of the device.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new event information received.

• Brand Name: TURBO-JECT POWER INJECTABLE
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8156296
• Report Number: 1820334-2018-03536
• Device Sequence Number: 11192859
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)200622(10)8972289
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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: Health Professional
• Device Expiration Date: 06/22/2020
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1110
• Device Lot Number: 8972289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/23/2019; 02/18/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/23/2019; 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1